Optimizing multicomponent interventions using The Multiphase Optimization Strategy (MOST)

July 07, 2023

Speaker LaRon E. Nelson

Thursday, November 3rd, 2022 at 2:00 pm.

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00:07<v ->People join.</v>
00:10We can just let them in.
00:11So I just wanna say good afternoon.
00:13My name is Christine Simon.
00:15I am an associate research scientist
00:17in the Department of Social and Behavioral Sciences,
00:20and at the Center for Methods in Implementation
00:22and Prevention Science here at Yale School of Public Health.
00:26I am delighted to introduce our Ready Hub
00:29webinar presentation and presenter, Dr. LaRon Nelson.
00:34But before I do that, I just wanted give you
00:37a little bit more information about our hub.
00:40Leveraging the expertise of Yale Center for Methods
00:43in Implementation and Prevention Science
00:46and Center for Interdisciplinary Research on AIDS,
00:50Ready, R3EDI, the Rigorous, Rapid and Relevant
00:55Evidence Adaptation and Implementation
00:58to Ending the HIV Epidemic.
01:01Implementation Science Hub provides technical assistance
01:05to more than 10 Ending the HIV Epidemic projects
01:09from around the country.
01:11Ready, we have so many acronyms. (chuckles)
01:13Ready does this in collaboration
01:16with the Implementation Science Coordination,
01:19Consultation and Collaboration Initiative,
01:22also called ISC3I,
01:24creating opportunities to translate local knowledge
01:26into generalizable knowledge whenever possible.
01:31Ready offers comprehensive expertise
01:34in implementation science methods, frameworks
01:36and outcomes in HIV AIDS research.
01:40I just also wanna let everyone know that this event
01:43is co-sponsored by the Yale Center for Methods
01:46in Implementation and Prevention Science,
01:48also known as CMIPS, and Yale Center
01:51for Interdisciplinary Research on AIDS,
01:54CIRA and ISC3I.
01:57So if you would like to know more
02:01about future Ready Hub webinar events,
02:04please notify Dr. Debbie Humphries in the chat,
02:07and she'll make sure that you're added to our email list.
02:10So today's presentation is titled "No Black Men Left Behind:
02:17Conundrums and Considerations for Designing
02:20a Multi-Level Hybrid HIV Implementation/Efficacy Trial."
02:24And it is being presented by Dr. LaRon Nelson,
02:28who is the Associate Dean for Global Affairs
02:31and Planetary Health and Independence Foundation
02:34Associate Professor of Nursing.
02:36I just wanted do a quick background on Dr. Nelson.
02:40He has so many accomplishments,
02:44but just to highlight a few.
02:46Dr. Nelson's domestic and international research
02:49investigates the implementation and effectiveness
02:51of multi-level intervention strategies
02:54to reduce race and sexuality-based disparities
02:57in HIV outcomes.
02:59He's recognized as the world's leading authority
03:01on the application of self-determination theory
03:04for HIV prevention and care.
03:06His research also involves identifying interventions
03:10to address intersectional stigma at the organizational level
03:14and treating the traumatic effects of intersectional stigma
03:17that manifests at the individual level.
03:21His work in research and implementation science
03:23spans multiple countries.
03:25He co-founded the Central and West Africa
03:28Implementation Science Alliance,
03:30a collaboration of implementation scientists
03:33in implementing agencies from Cameroon, Congo,
03:36Ghana and Nigeria, aimed to improve HIV-related outcomes
03:42among adolescents in the region.
03:45He is also leading implementation science efforts
03:47to reduce racial disparities in HIV incidence,
03:50treatments and viral suppression
03:53among African, Caribbean and black communities in Canada.
03:57His work in the US focuses on the, excuse me,
04:01his work in the US focuses on the use of multilevel
04:05social, structural, behavioral and clinical interventions
04:08to reduce HIV infections among black MSM.
04:13He's also currently part of a multiple EEG supplement
04:17addressing rapid PrEP and HIV prevention.
04:21It is with great pleasure that I turn this presentation
04:24over to Dr. Nelson.
04:26Thank you so much for doing this.
04:28<v ->Thank you, Chris, for that introduction.</v>
04:30Welcome, everyone.
04:31Thank you for making time with this presentation.
04:35What I'm gonna do today is perhaps a little bit different
04:39because I won't be presenting on outcomes of research,
04:42but this is essentially a presentation
04:46and discussion about research and progress.
04:50Slides are loading in progress.
04:52Let's see if we can get 'em up here.
04:55And so this is the title,
04:58"No Black Man Left Behind."
05:01Really thinking about what were some of the conundrums
05:04and things we should be thinking about for designing
05:06a multi-level hybrid HIV implementation/efficacy trial.
05:11And hopefully some of what we're learning,
05:14what we've learned, and what we are learning can help
05:17those of you out there who are thinking
05:19about similar types of work and the opportunities it offers,
05:23but also the challenges that are involved.
05:27The work today I'll talk about was done in collaboration
05:31with a lot of people, but principally with Chris Beyrer
05:34who's at Duke University.
05:36He's the director of Duke Institute for Global Health,
05:39and Bob Remien.
05:41They're not here today presenting today,
05:42but because this webinar we'll talk exclusively
05:46about HPTN 096, it's important for you to know
05:49that three of us are leading that together.
05:52So right now there's still a marked racial disparity
05:55in the coverage of PrEP.
05:57If we look at the most recent data from the CDC,
06:00this is what the slide is showing.
06:03And this is from 2019.
06:05Overall, the nation is still at about a quarter
06:09of people who are eligible for PrEP
06:13have been prescribed PrEP.
06:15So that's about halfway towards the EHE goal
06:19of getting to 50% by 2030.
06:22However, that 23% really is driven principally
06:25by the high degree of PrEP prescription among whites.
06:32So that is 63%.
06:33If you look at Hispanic and Latino, is 14%,
06:38and blacks including African-Americans
06:40are not even 1/10.
06:43And so the large number among whites
06:46mask the disparity that exists,
06:49black folks who are eligible for PrEP
06:52are not being prescribed PrEP and thus black not using PrEP.
06:56We see similar, although not as stark source of patterns
07:00with viral suppression, there are still racial gaps.
07:05You see overall the rate is about,
07:08the proportion is about 66% of people with HIV
07:12being virally suppressed in 2019.
07:15But if you look across three racial groups,
07:18just social groups, mind you,
07:20that blacks and African-Americans represent 61%.
07:25Only 61% of those with HIV are virally suppressed
07:28compared to Hispanics and Latino, which is slightly higher
07:32and then highest among people who are white.
07:38And then the HV epidemic itself is also,
07:40there are disparities geographically.
07:42We know that the epidemic really is concentrated
07:46in southern US states.
07:48Ton of social, structural and behavioral reasons
07:52for that also, but what you see on the map on the left
07:56is the HIV prevalence.
07:59And you can see that it really does pool
08:02along the South Atlantic seaboard,
08:06even Atlantic Coast more generally,
08:08across the Gulf of Mexico states.
08:12The map on the right shows you a similar pattern.
08:14These are HIV diagnoses by US county.
08:18And again, along the southeastern Atlantic coastline
08:22across the Gulf of Mexico,
08:23you see that those where we're having the most cases.
08:28And then if we look more specifically
08:30at black MSM in the South,
08:34you find that they are highly overrepresented
08:38in new HIV cases.
08:40So what you see on this slide are cases of HIV,
08:47new diagnoses of HIV among men who have sex with men,
08:51grouped by region: Northeast, Midwest, South and West.
08:57So you can see clearly that most of the new diagnoses
09:00are happening in the South among MSM.
09:03That accounts for more than all the diagnoses
09:07in other regions put together is in the South.
09:10And if you look specifically in the South among MSM,
09:14black MSM represent the vast majority of the cases
09:19among MSM in that region.
09:24And then this is perhaps one of the most important slides
09:28I'll show you in terms of background,
09:31is that there have been several innovations,
09:35biomedical innovations that should have an impact
09:39on HIV incidence.
09:41There's some things that are done in HPTN,
09:44the HIV Prevention Trials Network.
09:46So in a 052 study, they establish U=U,
09:50that if a person is virally suppressed and undetectable,
09:54they cannot transmit the virus.
09:56There was discovery of the efficacy of oral Truvada for PrEP
10:04and then the introduction of rapid HIV test cases
10:07that could be taken at home.
10:09All very important innovations.
10:12And what you see that between 2010 and 2019,
10:18that those innovations, you know,
10:20we can't say that it was a direct link to it,
10:26but if you just look at how the graph along that timeline,
10:29that you see that the HIV incidence among white MSM declined
10:34over time pretty much corresponding with introduction
10:37of these new innovations.
10:40And that's not unusual, that's not unexpected.
10:44That's the reason why we do,
10:46scientists do this type of research
10:47to have an observable impact.
10:52So you've seen that among white MSM.
10:54But at the same time,
10:59that trend among black MSM from 2010 to 2019
11:05is relatively unchanged.
11:07Even with the evidence of U=U,
11:11even with the introduction of Truvada for PrEP,
11:14even with the introduction of rapid home test kits
11:16that those, the introduction of those innovations
11:20into the health system or the healthcare marketplace
11:24has not seemed to have any impact
11:27on the the HIV incidence among black MSM
11:30in that 10-year time period.
11:33And so there are reasons for that.
11:37And I think in the HIV prevention world,
11:40many of the reasons that we've investigated for many years
11:44have been behavioral reasons
11:47'cause they must be have more sex than the white MSM,
11:51or that's probably the principle reason
11:54that we've investigated and ways to sort of minimize
11:58people's exposure to HIV through sexual behavior.
12:03But through a lot of work,
12:04including some work that's happened at Yale,
12:05we know that there are other factors
12:08that are structural factors and social factors.
12:13I won't even give an examples of them right now,
12:15but, or maybe I will give an example.
12:18So even more recently in the US District Court
12:24out of Tarrant County, Texas, that's Fort Worth,
12:28there was a recent ruling that employers
12:33were no longer obligated to provide coverage
12:38for PrEP as part of their insurance plans.
12:42And so if they're black men, white men, black women,
12:47Hispanic women who wanted to take PrEP,
12:52there will be barriers to taking it
12:54if their employer didn't cover it, right?
12:56That's not a behavioral factor.
12:59That's a structural factor that can impede
13:02the ability for communities to achieve prevention goals.
13:06And so that's just one very recent example.
13:08But there are a number of examples that,
13:10over time, we've come to understand that
13:12the situation is much more complex than getting a person
13:16to do a thing, that the way systems and social norms,
13:20stigmas confront and constrain people's ability
13:23to enact the behavioral goals has an impact
13:26on this epidemic.
13:27And we contend that this is, more than contend,
13:32we understand that this is part of what is happening
13:35with why we can have the development of these types
13:38of innovations and not have an impact on black MSM
13:41in terms of what we see with the viral suppression data
13:45or the incidence data is because there are
13:48structural factors that are making that
13:50very difficult to attain.
13:53So what we decided to do with HPTN 096
13:56was to develop and test an integrated strategy
13:59that dealt both with behavioral factors,
14:02that dealt with social factors,
14:04and that dealt with structural factors.
14:06And so we identified interventions that address
14:09all of those things.
14:11And we're testing this, well,
14:14there are four components of that intervention.
14:17The first is social media influencers.
14:22So I thought was that we have to tackle
14:25this at multiple levels.
14:27We can't just have another study where we enroll a cohort
14:30of black men and zero in an intervention on them
14:35and follow them over time.
14:37Because that that essentially
14:39is a behavioral-focused intervention.
14:41They needed something that addressed these issues
14:43at multiple levels.
14:44And so the first component was to use
14:46social media influencers who could really have an impact
14:50on norms, norms around stigma,
14:53norms around HIV prevention and HIV treatment.
14:57A second component to that was a culturally-responsive
15:01intersectional stigma prevention, or CRISP for short.
15:05That is an intervention that is targeted specifically
15:07at healthcare facilities.
15:10Because the experience that black men have
15:14when they're going to facilities can either optimize
15:17their prevention goals or treatment outcomes
15:19or can undermine it.
15:21And so we thought, beyond doing something
15:23that was at the community level,
15:26that it needed to be something that was focused
15:28at transforming healthcare environments,
15:31so intervention focused at the organizational
15:33or institution level.
15:36There's a peer support component
15:37which is a behavioral-focused intervention
15:40that is targeted towards black men,
15:43black MSM specifically in this study,
15:46that's designed to offer them access to peer support
15:49that's not, doesn't require them to have to meet in person,
15:54which is de facto disclosing people's sexual identity,
15:59which may not be acceptable in some of the places
16:01where the study is happening.
16:03And then the last one is the health equity-focused
16:05intervention, which is the structural intervention.
16:07This is a coalition model where people are coming together,
16:13people, organizations are coming together
16:16and finding different ways to cooperate, right?
16:19The system is the design a particular way,
16:22but we're saying the system's not serving black men,
16:25they're not serving black MSM in particular.
16:27And so how might you cooperate, the church,
16:32the employment agency, the immigration office,
16:34the health department, the police department,
16:38the rape trauma center, how might you, the food bank?
16:42Is there a way to restructure how you work together
16:45that's gonna help bridge these gaps that the men
16:48are falling through and it's contributing to the reason
16:51that we're not seeing incidence decrease
16:54and viral suppression rates increase?
16:58So those are the four components of the intervention.
17:01CRISP, peer support, social media influence
17:03and health equity.
17:04So we said, "Okay, if we do these four things together,"
17:07right, if we do this multi-level strategy
17:10that are addressing issues that we know are complicating us
17:14achieving this goal with black MSM,
17:17we can increase rates for HIV testing.
17:19And then among those who don't have HIV
17:21increased the use of PrEP.
17:24At the time we only had oral PrEP,
17:25but even with injectable PrEP.
17:27We can increase that and then increase the proportion
17:29of black MSM who are protected from acquiring
17:33an HIV infection if they're exposed.
17:36And then among those who are diagnosed,
17:37we can increase the uptake in adherence to ART
17:40and increase the proportion of those black MSM
17:43who are virally suppressed.
17:44And if we can do these things,
17:46which is consistent with the EHE strategy,
17:48these are three parts of the pillar,
17:51that we can reduce HIV incidence among black MSM
17:54in the South, because that's personally
17:57where it's concentrated.
18:00So we're testing this, the things I described to you.
18:04We don't know that it will work.
18:06We hypothesize that it will work, but we don't know.
18:10How we plan to know what's do testing it
18:12in this cluster randomized controlled trial.
18:15It involves 16 communities.
18:18It involves delivering the integrated strategy
18:22and the intervention communities.
18:24And the communities who are randomized to standard of care
18:27will continue to do whatever it is
18:29that they're doing in their communities
18:30to advance their EEG goals, but without the added,
18:34the addition of the integrated strategy.
18:37And then we're measuring our out points at,
18:40we're measuring out our endpoints in two ways.
18:44The first is we're looking at viral suppression
18:46through partnership with the Centers for Disease Control.
18:48So we'll look at surveillance data to see whether or not
18:51our intervention, the way that is applied,
18:54if can have an impact on CDC surveillance
18:56of HIV viral suppression among black MSM.
18:59And then we are doing an assessment,
19:02a cross-sectional assessment of black MSM sampled
19:06from each community to determine the prevalence
19:08of PrEP uptake in those communities.
19:12So these are the 16 communities.
19:15We group them into pairs,
19:17and we randomized within each pair.
19:22May not be able to see it well,
19:23but the communities that have the stars next to it
19:26are the ones who are randomized
19:29to the intervention community.
19:34And we started this in a pilot.
19:36So we started a pilot maybe earlier 2022,
19:42seems like longer than that.
19:44So we're piloting it and two pairs,
19:47which is about coming to an end of that phase.
19:49That's Dallas and Houston, Texas being one pair,
19:52with Dallas as the intervention community.
19:54And then Montgomery, Alabama and Greenville
19:56being the second pair in Montgomery was the,
19:59or is the intervention community.
20:02I think we developed this beautiful logic model.
20:06This is based on the implementation research logic model
20:09that I think came out of the team at Northwestern,
20:12which is also part of ISC3I.
20:14So we use this to think about how would we implement these,
20:19this intervention strategy given that's gonna be implemented
20:23in places where it requires people who work
20:28in organizations to take the intervention and use it.
20:31So it's not a sort of classic drug trial
20:33where you enroll people, you give them an intervention
20:37or a pill and you see the outcome.
20:41These organizations have some role
20:44in taking these strategies and improving their practice
20:47for us to see the outcomes.
20:48So we need to think about what are the things
20:50that are gonna influence that, what are the determinants?
20:53How might we influence that?
20:54And that's the implementation strategies.
20:56That's what our integrated strategy is,
20:58an integrated implementation strategy.
21:01And then we map the outcomes based on what we think
21:04the mechanism of action will be.
21:06And so again, in this study,
21:08we're not testing the efficacy
21:10of the biomedical innovation.
21:14These clinical interventions exist.
21:16What we're trying to do, in a sense,
21:20is test how can we get them scaled,
21:23taking the scale in these communities,
21:25and can we also observe the impact of scaling
21:28in these communities in our final outcomes
21:30which are viral suppression and PrEP uptake.
21:35So these are the considerations
21:38that I wanted to sort of get into.
21:40So the first thing in doing something complex as this
21:44is community engagement is very important.
21:50Neither Bob or Chris or I live,
21:55Chris lives there now, but live in this place
21:58where we're gonna do this study.
22:00And even if we did, we didn't live in all the places that,
22:05we didn't live in every neighborhood.
22:07We weren't familiar with every place in this region.
22:09And so community engagement was gonna be key.
22:12We needed people who knew what it was to live in the South,
22:16who knew what it was to live the black social experience
22:20in the South, who knew what it was to be a man
22:24who has such desired for other men,
22:26or who engaged in sex with other men,
22:28or who identifies as gay bisexual
22:30in that geographic context.
22:33So we spent a lot of time designing a strategy
22:36that would really infuse community engagement
22:38throughout everything that we did.
22:41It was really a three-level strategy.
22:45The first was helping to raise general awareness
22:48about the study through local stakeholders
22:51and through national stakeholders
22:52who were recognized members of the community.
22:55Then we had a community specific-engagement component,
23:03which is really designed to make sure folks
23:06understood these different elements
23:08of the integrated strategy,
23:11but also that community members could inform
23:13our development of these elements
23:15of the integrated strategy.
23:17And then the third was making sure we could identify people
23:20who could participate in the cross-sectional assessment,
23:23or baseline survey and sampling.
23:26And, initially, we had three types of groups
23:32that we identified or assembled:
23:34a community strategies group which was really a group
23:38that provided strategic guidance to us.
23:40These were folks who were involved in healthcare
23:45and policy and research in different parts of the country,
23:48mostly in the South but not exclusively in the South.
23:51It helped us think about how we were designing this study,
23:54what we should be pursuing, what pitfalls we should avoid.
23:59A community advisory group,
24:00which was our primary advisory body for the study.
24:03These were made up of people who really,
24:07they had to live in the community.
24:08So we had at least two individuals,
24:12not all black men, but mostly black men
24:16who were from each of the 16 communities
24:18where the study was being conducted.
24:20It didn't matter whether it was the intervention community
24:22or standard of care.
24:23We needed people from there who could really help us
24:25understand what we needed to be doing
24:27or be aware of in these communities.
24:30And then finally, we had community liaisons
24:33who really were our gatekeepers.
24:34These were the people, you see them across the bottom
24:36of the screen, who were our connection to the communities,
24:42both me as one of the protocol chairs
24:45and also our senior research managers.
24:46They helped us understand what was going on
24:49and were really the ambassadors, if you will,
24:51for the study in their communities.
24:54These represent Dallas, Texas, Montgomery,
24:58Greenville and Houston, Texas,
25:00Greenville, South Carolina and Houston, Texas.
25:04And we obviously had to do a lot of communications.
25:08And so this is just showing a couple things,
25:12a website was developed to make sure people
25:14could go to it and understand aspects of the study.
25:19We presented at multiple conferences at community events.
25:23And then we had to also in some ways
25:26sponsored community events.
25:28I mean, I think typically,
25:33and I think we suffer from this also in this study,
25:35is we see the community component
25:40as a bit of a added benefit or a luxury.
25:46And what it means is that when we allocate budget,
25:49we allocate it towards the things that are key or important.
25:52And if there's money left over to do the nice-to-have things
25:56but not essential things, then you might sprinkle,
25:58(chuckles) you might put some money in those areas.
26:03But I think that's a mistake.
26:04The community engagement part is essential.
26:08There's no way we could even get to these places
26:11and try to implement half of what we've done
26:14were it not been for our engagement.
26:16And it also can't just be transactional.
26:20And I mentioned this because I mentioned a few moments ago
26:23about the need to sponsor events.
26:26So the trials and investment in the community
26:29had to be more than you being able to bring us participants.
26:33So we had to be there and also show interesting things
26:36that they were doing,
26:38even if it was not directly tied to the study,
26:41that they can be constrained to that,
26:43if your grant funder doesn't approve for you
26:44to do certain things with the fund that promote this.
26:48But had we not done these things,
26:49I think it's quite likely that
26:53we would not have been welcomed or not seen
26:55as serious partners in some of these community areas
26:59where we were.
27:00And so the community investment is a key consideration,
27:04I think is also a common pitfall
27:08that happens when you're designing studies
27:10and particularly how you're resourcing trials.
27:18So we did the baseline cross-sectional assessment
27:22in four communities.
27:23And three of the four, we've already reached our target.
27:27So we did this because the intervention is being applied
27:31at the community level, as I mentioned before,
27:33we're not following a cohort.
27:37So because we're not doing that,
27:38we needed to use a sampling method that we thought
27:41could give us (sneezes),
27:45that we thought could give us a population estimate
27:49that we could sample this way and have a pretty good sense
27:52that this is what's happening in the community,
27:54both that baseline and when we do our follow-up assessment.
27:58And so we use this Starfish sampling method.
28:02And what you'll see, this is data as of Monday
28:07that we've reached our target.
28:09The target is 100 people per community
28:12in the four that were in the pilot.
28:14So we reached our target three of the four communities,
28:19in some ways exceeded the target.
28:22Are there reasons that we had to always (indistinct)
28:23some places, but at least in three,
28:25we have reached at least 100 people that were enrolled.
28:28And in one community we're a little bit ways away
28:31from reaching the 100 'cause we're currently at about 80.
28:36So here is the challenge.
28:39We think there are some assumptions about Starfish sampling
28:45that, not even some assumptions
28:50about that might be cultural that might not really reflect
28:52the way that black communities operate
28:55or move about in the South.
28:57And there are also some constraints.
28:59So for example, in order to try to reach
29:02a representative sample, you can't just go to a party
29:07or event and talk to every person that you encounter, right?
29:12In some sense, that becomes a convenient sample.
29:16And so they've had to space out how many people
29:21they could when they would count a person.
29:23So every third person could be recruited,
29:25and then up to 10 people per event.
29:28And then you would stop recruiting,
29:30and you wait for another event.
29:31You'd approach every third person,
29:32up to a certain number of people at a time.
29:36And so, from a statistical standpoint,
29:39you can understand why that would be important to do
29:41if you're trying to achieve what Starfish
29:43is supposed to provide in terms of representativeness.
29:47But it does create challenges because it does not,
29:53it imposes constraints.
29:56So for example, it takes much longer to recruit people
30:01in these contexts using Starfish
30:04because, especially in COVID,
30:06there are not sort of regular normal places
30:09where black gay men or black MSM
30:11can gather in a place like Montgomery, Alabama
30:15or a place like Greenville, South Carolina,
30:17or even some parts of Texas.
30:20And so the opportunities to recruit become smaller
30:24in places where you don't have an infrastructure
30:26that's set up where there's normal gathering places
30:29for black sexual minority men, right?
30:32So this was a conundrum.
30:33We want to use this strategy because we wanna have
30:36some rigor and understanding that the sample that we got
30:39represents the community overall.
30:42But it's hard to implement this (chuckles)
30:44because of the parameters of how you have to operate it,
30:46which means it's gonna take us a much longer time to do it,
30:49and the studies already started.
30:50And so we don't wanna still be recruiting a baseline sample
30:55at the point that we already had to,
30:56we don't wanna be recruiting the baseline sample
31:00at the point where we've already had to start
31:02implementing the study because it's taking so long
31:05and we can't wait to get the sample
31:07before we can start because of timelines.
31:09So that was a conundrum but something to consider.
31:14For social media influencers,
31:16we had influencers
31:20from at least each community.
31:25This was also very exciting for us
31:29because of the potential impact
31:31and reach of social media influencers.
31:35But it also had some conundrums for us, some challenges.
31:39So the first is that because we are testing this
31:42in a randomized controlled trial,
31:46we were very concerned about contamination,
31:49that we have to find social media influencers
31:55whose influence is really isolated
31:59to the intervention communities,
32:01because we didn't want them influencing people
32:03in our standard of care communities,
32:06not for the intervention component.
32:08And so the first is that is hard to do.
32:11The people that have the most influence,
32:14their influence is not isolated. (chuckles)
32:16Their influence is broad,
32:19and having people like that violates
32:23one of the principles of conducting
32:26a randomized controlled trial.
32:28But if you can identify influencers
32:32who have very limited reach,
32:35which can allow you to have a social media influencer
32:38that will not have such a broad reach
32:40that they would contaminate other communities,
32:43it doesn't really allow you to, (chuckles)
32:45it doesn't really meet the intent
32:47of the social media influence because you need somebody
32:50with limited influence in order to conform
32:52the parameters of a trial.
32:54And if you got influencers who really have broad influence
32:57and people would listen to,
33:00that that would quite easily violate
33:01the parameters of conducting
33:03a randomized controlled problem.
33:05So we've had to learn from this.
33:07One of the ways that we thought about
33:10is that we might have to relax that
33:16and think about, you know, what we would lose
33:18by having a broad influencer who might have influence
33:22in some of the other communities
33:24compared to what we would gain by having an influencer
33:27that could really represent
33:29what this intervention is supposed to be.
33:32For peer support, these are,
33:35the pictures that you're seeing are the people on the team.
33:38And so these are our six peer supporters,
33:41and Antoine Jackson who is their clinical supervisor.
33:45As I mentioned, the peer support is designed for,
33:49it's online, and you don't have to be signed up
33:52with any particular agency to receive the support.
33:57We train them, we train them intensely,
34:02over 40 hours of training.
34:04And we develop a comprehensive promotional program
34:10to get people to participate.
34:13And we didn't have, at least right now,
34:15robust participation.
34:17And we try to understand mostly with the help
34:20of our community advisory group why that might be the case.
34:26And partly because peer support requires trust,
34:31and trust takes time to build.
34:33And that this trust building really was not
34:38aligned with the study timeline.
34:41In some of these places where there's high degrees
34:44of stigma where living as an out black gay man,
34:47or even if you're not out, people finding out
34:49about your sexuality if it's a minoritized sexuality,
34:53can have very serious consequences for people.
34:55And so for folks to access these things,
34:57for even show on their phone as an app,
35:00folks have to trust that it's not gonna get them
35:03in some type of trouble or situation
35:06they don't want to be in.
35:07And that building that type of trust takes time,
35:11and more time than we had (chuckles) for the study timeline.
35:16And so we didn't have great uptake
35:18in this particular component in the timeframe
35:21that we were trying to look for,
35:22which I think it was probably too narrow.
35:25And so one of the things that we considered
35:26is that we probably don't need a centralized
35:30peer support program not connected to an agency.
35:34The reason we had a centralized program
35:37is because people were concerned that in order to get
35:42peer support you had to go to the Spiegelman clinic.
35:44And if you're not a patient at the Spiegelman clinic,
35:46you don't have to become a patient just to get peer support
35:50or go to the Nelson Health Center to get peer support
35:52if you wanted a patient there
35:53or if you didn't like going there.
35:55And so we had that information from the community early on.
35:59So we said we shouldn't anchor it to a clinic
36:01because then that will serve as a barrier.
36:04But, in thinking about that,
36:07we think it may be better to not anchor it
36:09into a particular clinic but to offer the program
36:13to resource multiple organizations in the community
36:16so that people had options so that the peer support program
36:19was not tied to the identity of any one particular clinic.
36:23But because those clinics and organizations were trusted,
36:26hopefully trusted organizations,
36:28that this could facilitate the implementation in ways
36:31that trying to do it centrally from a research site
36:34cannot accomplish in the timeframe
36:35that we needed to accomplish for the trial.
36:40And then this next one is really the CRISP.
36:44And this is the component I spent quite a bit of time on.
36:47Again, CRISP is focused on healthcare facilities,
36:50really to reduce the amount of stigma
36:56that people experience when they go there,
36:58both in interpersonal interactions
37:00but also in how services might be delivered.
37:04And CRISP has these five components:
37:07client observation visits,
37:08which are simulated clients that we train
37:12who go in as patients, simulated patients,
37:15and have an experience in that clinic
37:16and then have the ability to offer feedback
37:18about what it was like to be a black gay man
37:21and playing that character in that clinic space,
37:25or CBO space, but mostly these have been clinics.
37:29Or providing a foundational training
37:31which is basically 12 contact hours of stigma reduction
37:35intervention workshop.
37:37And then quality improvement, which is how we take
37:39what we've learned and translate that into service changes.
37:46So we worked, we tried this with four facilities.
37:52One is Parkland Hospital,
37:53which is a large public safety hospital in Dallas, Texas,
37:58and Abounding Prosperity, which is a community-based clinic,
38:01organization with the clinic in Dallas, Texas,
38:04and then MAO, which is in Montgomery, Alabama.
38:08They have a treatment facility and a prevention facility.
38:11So we were able to, this green that you see is showing
38:14that we completed surveys,
38:17we had simulated client instructors,
38:19observers go in and make those visits.
38:22And we met all our training goals,
38:23which really was that we could get 75% of people
38:27in those facilities who do HIV prevention work
38:30or are along that HIV prevention or treatment pathway,
38:33that we could get at least 75% of those people trained.
38:37And we had as much as 99% coverage in some places.
38:41Parkland was at 77%, and Abounding Prosperity at 83%.
38:48But those are great successes,
38:50but they're also challenges to it.
38:53The first is that
38:59we have to have a pretty strong business case for doing this
39:04in healthcare facilities or a pretty substantial incentive
39:08because the time that the facilities take out
39:11to participate in this, the stigma reduction intervention,
39:15which is important, but it is time that they're not spending
39:19doing things that they could be billing for
39:21and generating revenue, which is not trivial.
39:27So it's something we have to think about to do.
39:31We did provide an intended, which we thought was fair,
39:36in the design.
39:38But in the implementation, it is becoming clear to us
39:41that sites are feeling that they're giving up a bit more
39:45to participate in this than is covered
39:48by the compensation that we provided them for participating.
39:52So it's something to think about because we couldn't do,
39:54we can't force the clinics to do it, to participate in this,
39:58but in order for us to reach black men and black MSM,
40:03we really have to be working in clinics
40:05where we know they'll go,
40:07they'll likely have to pass through to get care.
40:11Related to that is (chuckles)
40:14one of the things that we thought about is how can we,
40:20what number of clinics do we need to target
40:25to maximize the reach that it will get to black MSM?
40:28Is it 10, is it 20, is it 100?
40:32We can't afford 100 in each city,
40:35but we need some way of figuring out how we do that.
40:37For HIV primary care, that's a bit easier
40:39because those sites are relatively few in each city.
40:45So we could essentially target all
40:47HIV primary care facilities.
40:50And this chart here is showing you what we would do.
40:52So there are four facilities, that if we targeted them
40:57and check (indistinct) stigma reduction,
40:59we would be in facilities that had patient volume
41:03that accounted for 65% of the black MSM living with HIV.
41:07This is in Shelby County, Memphis, Tennessee.
41:10So for four clinics we could get 65%.
41:13Those clinics would cover 65% of black MSM.
41:16And then if we get additional four clinics,
41:18we can get as high as 80%.
41:21But then after eight clinics, the additional yield,
41:25the additional coverage we would get
41:26gets smaller and smaller and smaller.
41:29So that's something to think about is how we,
41:31that we're thinking about, is how do we get coverage
41:36in terms of population coverage of black MSM,
41:39but we don't have a lot of time
41:41and we don't have an infinite amount of money to do it.
41:44But we could at least accomplish quite a big yield
41:47in HIV primary care.
41:49The larger challenge for us though is in trying to find
41:54the right coverage, the maximum coverage for facilities
41:58who provide PrEP or who could provide PrEP.
42:02Because essentially that's any primary care facility
42:07anywhere should have the capacity to provide PrEP.
42:11And so we're trying to figure out what that is.
42:15The other challenge in trying to figure out that number,
42:18the imperative, I guess I would say,
42:22is that we can't end up with an intervention strategy
42:25or healthcare facility strategy that can only be done
42:29in the context of a trial like this,
42:32that could never be done.
42:34But the CDC would say there's no way we could support this
42:38in our budget, or that agencies in these communities
42:41across the country with this or get
42:43taken up by the CDC would say,
42:44"How could we ever lift this up?"
42:46'Cause you have the sample 100, no 100,
42:49let's say 20 facilities in a small community.
42:52There's no way we could do that.
42:54So what we're thinking about now is taking an epi-focused
42:58approach to selecting the healthcare facilities
43:01for the stigma reduction.
43:04That is looking at global information systems data,
43:10or GIS data that should be available
43:14from health departments.
43:15Understanding what are the high STI burden census tracts
43:20in these areas and what clinics are in those areas.
43:25Because the HIV risk, as we saw earlier,
43:29is not evenly distributed, even probably across communities.
43:32There are probably certain communities where STI
43:35as an indicator of risk of acquiring HIV
43:40are more concentrated or more prevalent than other parts.
43:43So we are thinking we should find out where those places are
43:47and what clinics are in those places,
43:50and in what proportion of that census
43:54in those clinics or the patient role
43:56are black men represented?
43:58And I say black men because in many of these places,
44:01we don't have a denominator for black MSM
44:04for a lot of reasons.
44:05Why it doesn't ask question, or they ask the question
44:08and the person is, the man is not comfortable
44:10telling the provider about that aspect of their behavior
44:13for a variety of reasons.
44:15And so we don't have reliable estimates of black MSM
44:18from a prevention side in many of these places
44:22in almost all of these places.
44:25And so, but we do know the number of black men.
44:28And so if we can identify the places,
44:34the highest number of cases of STIs among black men,
44:37if we can reach those black men,
44:39black MSM are a part of that group.
44:41And so we're trying to figure out ways to determine
44:46how can we figure out where the highest need is,
44:48or the biggest impact that does not require us
44:52to try to sample all the clinics, which we cannot do.
44:55And even if we could do it,
44:57it is not a sound public health strategy
44:59because it probably could not be implemented
45:02in most places in the United States
45:04because of the heavy lift and the cost.
45:07And then we also thought about this idea of spillover.
45:11So if we can identify, let's say, index clinics
45:14that are in these places of high STI burden,
45:18then might there be a way to, if we reach those,
45:21that there will be some spillover effect
45:23in other parts of the community which can also help us
45:25reach that coverage.
45:28This is a paper by some of our colleagues at Yale,
45:32including my friend Donna Spiegelman and Sten Vermund
45:35that looked at that in one particular study.
45:38So it is something that we're trying to think about,
45:39is can we look at, can we use a targeted strategy,
45:45identify index healthcare facilities
45:48and then estimate some spillover effect
45:49to other parts of the community,
45:52which I think is likely impossible.
45:55And then the last component is the health equity component.
45:59Again, these are local community coalitions.
46:03They're both local and regional.
46:07In Dallas, we have Abounding Prosperity
46:08as the lead organization.
46:12And in Montgomery with the Medical Advocacy & Outreach,
46:15or MAO.
46:17And then the regional organizing agency,
46:19a coordinating agency is the Southern Black Policy
46:22& Advocacy Network, which is led by a black
46:26openly gay man, open living with HIV.
46:30And next week he might be the first openly black gay man
46:33with HIV serving in the Texas State House.
46:36He's on the ballot, I think he's gonna win.
46:40So this was also not without challenges.
46:45The first is that when we started this,
46:48we used a centralized model,
46:50which was with the Black AIDS Institute,
46:52which is, many of you may know it.
46:54It is a vitally important, famed institution
46:58in the black community and for the country.
47:02That partnership did not work out.
47:04And so the challenge with the centralized model
47:09is that, if the partnership doesn't work out,
47:11you have to start all over
47:12because if you only had one partner.
47:14So we thought that introduced too much instability,
47:17but we thought that made us
47:22too vulnerable to have one implementing partner.
47:26And so we decided to go to a local model,
47:28which I think was more culturally appropriate
47:31in many of these places to do a local model.
47:35So that has worked out well so far.
47:38Another challenge is that Medical Advocacy & Outreach,
47:42they filed for bankruptcy, I don't know,
47:46a week ago, two weeks ago.
47:48And so, we'd already learned from our experience
47:54with having our health equity component
47:58focused in one agency.
48:00And so we expect that for many of these agencies
48:03and many of these areas that we will have
48:06some that struggle and that might cease operations
48:11or change management or change ownership.
48:14So we don't treat this as an isolated incident.
48:17This is one of the structural factors
48:20that impacts HIV prevention goals among black MSM.
48:23What we had to do was figure out how do we build
48:25in some resilience in this model
48:27so that when those changes occur,
48:29which we expect will continue to occur
48:32as we do this in the other cities,
48:37that we don't become so unstable
48:38that we can't complete this intervention in.
48:41So what we did was the coalition
48:43happened to already be built in Montgomery.
48:46MAO had already designed a coalition.
48:49And so we tried to center the intervention
48:52as part of a co-owned community coalition,
48:56that it didn't belong to the organizing agency.
48:59So that if the organizing agency changed hands
49:01or for some reason they decided they didn't want to do it
49:04or they didn't meet grant contract deliverables,
49:07that the coalition could still function
49:11for a time till we found another agency to lead
49:14to serve as the lead organizing agency.
49:20And so just things that consider,
49:22as having gone through all these things.
49:26One thing that we realized,
49:27even though we're conducting a randomized control trial,
49:30that we have to figure out ways to adapt.
49:36We say sometimes, "We have to bend or we're gonna break."
49:39And I think we've seen that,
49:42that we try to figure out how we're gonna sort of
49:45adjust as we go along.
49:47So I would consider using a design that will allow you
49:49to adjust as you implement.
49:52What you see on the screen, this is a slide from a talk
49:56I saw Donna Spiegelman give about this approach
50:00that her and her team have come up with
50:02called Learn as You Go.
50:03And so we are looking at how do we implement
50:06this Learn As You Go into the study
50:08that's already been designed.
50:10It would be best to have thought about this to incorporate
50:13this from the beginning when we're designing the study,
50:15but we didn't have that luxury.
50:18We didn't have that foresight, I should say.
50:20So we're looking at how do we do this now
50:22so that we're not just sort of making changes here and there
50:25based on our subjective experience,
50:27but that that we have some data-driven estimates
50:31about where we need to make changes and how much.
50:33So I think this offers great promise
50:35to the work that we're doing.
50:37Community engagement is key, and has to be integrated
50:39with scientific considerations.
50:41You can't do it with just scientific model.
50:44You can't do it with just listening to the community voices
50:46without considering the science, you have to do both.
50:50There really is a need for more implementation
50:52and prevention science methods
50:53that respond to the realities of life for black communities.
50:58I mentioned the challenges of doing Starfish sampling
51:01in some of these places, the challenges of peer support
51:05and social media influence in some of these places.
51:07So our methods need to really be able to respond
51:10to the realities in some of these communities
51:13'cause they're not always designed with
51:15that cultural logic in mind.
51:17And again, it's not trivial.
51:19Might seem so.
51:20When you're trying to do it, you see where it comes out.
51:23And then the last consideration is that we need
51:26more rigorous design options that are not limited
51:30to the RCT or that can at least enhance the RCT.
51:34And I think LAGO might be one thing that could enhance
51:38what we're trying to do with RCTs.
51:40But if RCTs and some are the only things we have,
51:43it really is hard for us to test some of these interventions
51:46in some of these places, given the constraints
51:48that are already embedded within them.
51:52So I wanna just acknowledge a lot of people
51:55involved in this, including the people
51:57who support this through funding.
51:59And that's what you see on your screen,
52:00HPTN and many NIH institutes.
52:06And then I did want to just say
52:09sort of in a way of dedication to Dr. Dawn Smith
52:13who was a very key part of this study
52:16from the very beginning.
52:17She is scienced at the CDC.
52:20She led the development of the PrEP guidelines for the US.
52:25She died a few days ago, and I will miss her immensely.
52:30But the work that you see here and the things
52:32that we're doing really is part of her contribution
52:35to HIV prevention, practice, but also prevention science.
52:40And thank you.
52:47<v ->Thank you so much, Dr. Nelson.</v>
52:52This is such a great presentation.
52:53We only have two minutes left, and so I do wanna make sure
52:58that there are any questions that you're able to answer.
53:07<v ->Yep, I can stick around and see if there's any questions.</v>
53:11<v ->Yeah, we're hitting on. Anyone have any questions in that?</v>
53:15I'm looking. Okay, anyone has any hands up?
53:20Okay, we are like right at the three o'clock mark,
53:24but if there are any questions or anything comes up,
53:28please feel free to email me or, you know,
53:31and I can pass along to Dr. Nelson
53:33or email Dr. Nelson directly.
53:37Just wanna just thank you again so much.
53:42<v ->Yeah, it's my pleasure.</v>
53:44It's always a pleasure working with Ready,
53:46and I appreciate all the work that y'all are doing,
53:48including helping us.
53:49I didn't say that we had a Ready consultation,
53:52and it's been very helpful,
53:53so thank you again for the opportunity.
53:56<v ->Yeah, great talk. Great work.</v>
53:58Really important work, LaRon.