Still Climbin’: A Randomized Controlled Trial of an Intervention to Improve Coping with Discrimination, Address Medical Mistrust, and Reduce Health Disparities among Black Sexual Minority Men

Abstract: Black men, especially Black sexual minority men (SMM), are negatively affected by health and healthcare disparities: They show worse outcomes for preventable conditions and preventable complications from chronic conditions, and are less likely to engage with healthcare than are White men and women. Moreover, Black SMM display strikingly high rates of HIV and other sexually transmitted infections. Based on evidence-based theory that discrimination contributes meaningfully to disparities, we propose to conduct a randomized controlled trial (RCT) of an 8-session culturally congruent cognitive behavior therapy group intervention, Still Climbin’, which aims to increase effective coping responses to discrimination (from intersectional race and sexual minority identities) and reduce medical mistrust among Black SMM, with the goal of improving healthcare engagement and receipt of evidence-based preventive care. Still Climbin’ has a strong scientific basis in our prior pilot work, which found that the proposed intervention is acceptable to key stakeholders, feasible to conduct, and associated with improved effective coping. The specific aims are: (1) To conduct a randomized controlled trial to test the effects of Still Climbin’, a culturally congruent cognitive behavior therapy group intervention, on healthcare engagement (e.g., at least one ambulatory visit in the past 6 months) and receipt of evidence-based preventive care (e.g., chronic disease screenings) among Black sexually minority men; (2) To examine mechanisms of the intervention’s effects on improved healthcare engagement and receipt of evidence-based preventive care, including more effective coping skills and reduced medical mistrust; and (3) To examine potential moderators of the intervention’s effects (e.g., age, HIV-serostatus and other health conditions). In the context of established community-academic partnerships, we will conduct the RCT with 300 Black SMM, randomizing 150 to the intervention group and 150 to a wait-list control group. Participants will complete surveys at baseline and 3-, 6-, and 12-months post-baseline to assess the primary outcomes, and potential mediators, covariates, and moderators. Healthcare engagement, receipt of evidence-based care, and health conditions will be verified with medical records. With the exception of our own work, we are not aware of any interventions that address coping with discrimination from intersectional identities in order to improve health outcomes among Black SMM. Our research is consistent with Healthy People 2020, which recommends developing interventions to address effects of discrimination among sexual minority individuals. Although structural-level interventions are critical for reducing societal discrimination as a long-term strategy, individual- level interventions—such as Still Climbin’—are needed in tandem to reduce discrimination’s immediate health effects.

 

Project Number:5R01MD014722-03

https://reporter.nih.gov/search/o5468n5DokOS3FYxFf7EXw/project-details/10307134

 

 

Contact PI/ Project Leader

BOGART, LAURA M, SENIOR BEHAVIORAL SCIENTIST (LBOGART@RAND.ORG)

 

Organization

RAND CORPORATION

 

 

PUBLIC HEALTH RELEVANCE: Large racial/ethnic and sexual minority health and healthcare disparities exist for preventable conditions in the U.S., and discrimination is thought to be a major contributor. We propose a randomized controlled trial of an 8- session culturally congruent cognitive behavior therapy group intervention that aims to increase healthcare engagement and receipt of evidence-based preventive care by increasing effective coping responses to discrimination (from race and sexual minority identity) and reducing medical mistrust among Black sexual minority men.

 

 

Project Start Date: 10-February-2020

Project End Date: 30-November-2024

Budget Start Date: 01-December-2021

Budget End Date: 30-November-2022

 

 

NIH Categorical Spending

Funding IC: NATIONAL INSTITUTE ON MINORITY HEALTH AND HEALTH DISPARITIES/ FY Total Cost by IC: $566,690

MSM and Substances Cohort at UCLA Linking Infections Noting Effects (Masculine)

Abstract: This application in response to NIDA PAR 12-222 Cohort Studies of HIV/AIDS and Substance Use (U01) seeks to leverage extensive existing infrastructure and cohorts at the University of California, Los Angeles to launch a new cohort of substance using minority (Black or Hispanic) men who have sex with men (MMSM). The epidemic of HIV among MMSM in the US and locally in Los Angeles County (LAC) may be driven by effects of substance use on adherence to treatment regimens and bio-behavioral prevention and enhanced by high prevalence networks. Proposed investigators lead the science on studying associations between non-injection drug use, risk behaviors and infectious disease among MSM, and contribute a broad portfolio of inter-disciplinary work from immunology and basic science to epidemiology, prevention and treatment. The work proposed leverages existing cohorts including the Multicenter AIDS Cohort (MACS) and existing repositories and builds on preliminary work to guide assembly of a cohort for the study of basic and behavioral factors in younger MMSM who actively use substances and engage transmission risks. Establishing a cohort of young active substance users, particularly stimulant users, who have poor histories of antiretroviral treatment (ART) adherence as marked by measurable and clinically relevant Plasma Viral Load (PVL) will enable important tests of biological influences of substances on immune function in MMSM. This cohort is central to prevention and treatment efforts and will provide well-characterized, extensive repository samples for leveraged use with other cohorts, networks’ and individual’s studies. The MMSM will be: (i) HIV-positive with viral load >5000 copies/ml or (ii) HIV-negative at high risk for HIV infection (unprotected anal intercourse in the past 6 months). This unique cohort will facilitate studies on interactions between substance use and HIV progression and/or transmission, which are of critical public health significance. This cohort of MMSM will characterize: (i) effects substance use on behavioral and network level risk in exposed and infected MMSM on acquisition of HIV and other sexually transmitted infections (STIs: gonorrhea, Chlamydia, syphilis, Hepatitis C (HCV)); and (ii) the extent to which substance use in MMSM facilitates behaviors that transmit HIV compared to non-drug using MMSM. The application also proposes to develop and maintain a bio repository that is HIPAA-compliant, technologically-current and DAIDS Network interfaced that includes a scientific advisory committee. This cohort will comprise 620 MMSM with repeated data visits (from 1,080 MMSM). At least half of these MMSM will be active substance users and younger than age 30.

 

 

Project Number: 5U01DA036267-05

https://reporter.nih.gov/search/tyATmmCktE-kfQBMC4JEpA/project-details/9267958

 

 

Contact PI/ Project Leader

SHOPTAW, STEVEN J, PROFESSOR (SSHOPTAW@MEDNET.UCLA.EDU)

GORBACH, PAMINA MAE, PROFESSOR (PGORBACH@UCLA.EDU)

 

 

Organization

UNIVERSITY OF CALIFORNIA LOS ANGELES

 

PUBLIC HEALTH RELEVANCE: The public health significance of the work described is very high in that the project seeks to establish a cohort of minority men who have sex with men who are active substance users who are either HIV-positive and have measurable viral load (indicating intermittent antiretroviral medication adherence) or who are HIV-negative and engage high risk sexual transmission behaviors for sexually transmitted infections, including HIV, gonorrhea, Chlamydia, syphilis and Hepatitis C. It is the composition of this cohort that confers outstanding impact. Establishing the cohort and the corresponding UCLA Bio repository for storing samples from these cohort members will provide a matchless platform to investigate basic, biological and behavioral effects of active substance use, especially stimulant use (i.e., cocaine, crack, methamphetamine, amphetamine and Ecstasy) in minority MSM who are sexually active (i.e., younger than existing cohort members) and who are inconsistent with antiretroviral medications. Findings from the proposed set of specific aims and from future research that will be made possible by establishment of the cohort and the UCLA Biorepository will enable important tests of biological influences of substances, especially stimulants, on immune function and HIV infection in very high risk MMSM, both HIV positive and HIV negative. This novel cohort will optimize our chances to clarify fundamental questions that have challenged NIDA/NIAID in curtailing infections in these populations.

 

 

FOA: PAR-12-222Study Section: ZDA1-NXR-B(15)S

 

Project Start Date: 30-September-2013

Project End Date: 31-May-2018

Budget Start Date: 01-June-2017

Budget End Date: 31-May-2018

 

 

NIH Categorical Spending

Funding IC: NATIONAL INSTITUTE ON DRUG ABUSE / FY Total Cost by IC: $1,488,949

A Comprehensive Community-Based Strategy to Optimize the HIV Prevention and Treatment Continuum for Youth at HIV Risk, Acutely Infected and With Established HIV Infection

Abstract: America’s increasing HIV epidemic among youth aged 12-24 and our concurrent failure to identify, link to care, and achieve viral suppression among youth living with HIV (YLH) suggests the need to identify novel community-based strategies to leverage gateways and settings where high risk and infected youth can be engaged in HIV prevention and treatment. Scientific successes reducing HIV viral reservoirs among acutely infected infants, stopping HIV transmission from HIV-infected adults with undetectable viral loads, and documenting the efficacy of Treatment as Prevention (TASP) suggest strategies to reduce the trend of increasing adolescent HIV infections. This U19 will evaluate the usefulness of these advances for youth aged 12-24 at the highest risk of acquiring HIV- gay, bisexual, transgender youth (GBTY) and homeless youth (HY) – as well as youth living with HIV (YLH) in two HIV epicenters (Los Angeles and New Orleans). All GBTY and HY at five gay-identified community-based organizations (CBO) and homeless shelters will be screened over 18 months. From these screenings, a cohort of 220 YLH and 1,500 highest risk seronegative GBTY and HY will be formed. Over 24 months, this cohort will be repeatedly tested at four month intervals for sexually transmitted infections (STI) and serious drug use, and with 4th Gen HIV tests if seronegative, in order to identify acutely infected youth, engage youth in medical care, and monitor outcomes. Youth are triaged to: Study 1: Acute infection. Using 60 ARV-naive YLH with established infection as controls, we expect to identify 36 YLH with acute infection. All youth with acute infections will be aggressively treated with at least four highly potent antiretroviral therapies (ARV) and repeatedly assessed to examine if prolonged viral suppression is achieved, with reduced viral reservoirs to potentially allow ARV- free HIV remission. Study 2: Stepped care for YLH. Adapting strategies to manage chronic illnesses, we will conduct a RCT comparing a Standard Care Arm (repeated assessments every four month and an Automated Messaging and Monitoring Intervention [AMMI]) to Stepped Care. In the Stepped Care Arm, increasingly more intense interventions are delivered if viral load is detectable: a) the Standard Care Arm; b) an AMMI that is tailored to comorbidities of the specific YLH; or c) a Coach to support during crises, make treatment referrals, and brief interventions. Dried blood spots will monitor viral load and, on a small sample, ARV adherence over time. Study 3: Engaging seronegative youth in the HIV Prevention Continuum. Youth will be randomized to either: a) an AMMI Arm; b) Peer-Support plus AMMI Arm; c) eNavigator and an AMMI arm; or d) Peer-Support plus eNavigator plus AMMI Arm. Each condition aims to optimize the HIV Prevention Continuum. An interdisciplinary team of basic, clinical, and applied researchers with expertise in HIV, STI, behavioral interventions, biomedical interventions, CURE research, perinatal HIV, and a history of participating and coordinating multi-site RCT is participating on this U19 from six universities.

 

Project Number: 5U19HD089886-02

https://reporter.nih.gov/search/HbqgtLEtKUG1ysdAGWkuMQ/project-details/9353195

 

 

Contact PI/ Project Leader

ROTHERAM-BORUS, MARY JANE, PROFESSOR (ROTHERAM@UCLA.EDU)

 

 

Organization

UNIVERSITY OF CALIFORNIA LOS ANGELES

 

 

PUBLIC HEALTH RELEVANCE: Project Narrative HIV among youth has doubled in the last 15 years, with incidence expected to increase 39% by 2020. If acutely infected youth can be identified and treated during the period when their infectivity to others is 5-to 10-fold, we can reduce this expected rise as well as improve youth’s long-term health, reflected in smaller viral reservoirs. The set of studies in this U19 tests a comprehensive set of strategies for acutely infected youth, youth with established infection, and seronegative youth at highest risk of acquiring and transmitting HIV –with policy implications for communities and the Centers for Disease Control and Prevention.

 

 

FOA:  RFA-HD-16-035Study Section: ZHD1-DSR-N(50)1

 

Project Start Date:30-September-2016

Project End Date: 31-May-2021

Budget Start Date: 01-June-2017

Budget End Date: 31-May-2018

 

 

NIH Categorical Spending

Funding IC: EUNICE KENNEDY SHRIVER NATIONAL INSTITUTE OF CHILD HEALTH & HUMAN DEVELOPMENT/ FY Total Cost by IC: $3,738,607

STI Screening as a Combined HIV Prevention Platform for MSM in Peru

Abstract: Periodic counseling, testing, and treatment for rectal sexually transmitted infections (STIs) provides a multi- dimensional platform to integrate behavioral and biological HIV prevention strategies for men who have sex with men (MSM) in Peru. Rectal STIs like gonorrhea and chlamydia are key risk factors for HIV acquisition among MSM, both as indirect behavioral markers of recent unprotected receptive anal intercourse (URAI), and as inflammatory factors that increase cellular risk for HIV co-transmission. However, there have been no prospective studies of interventions addressing the specific behavioral and biological risk factors associated with rectal STI transmission or the potential impact on HIV transmission risk of integrating rectal GC/CT screening with other prevention services. We will use nucleic acid testing to screen 750 behaviorally high-risk MSM for rectal gonorrheal and/or chlamydial (GC/CT) infection. GC/CT-positive subjects will receive single-dose antibiotic treatment and either single-session Personal Cognitive Counseling (PCC) (n=50) or standard post-test counseling (n=50). A GC/CT-negative control group (n=50) will also be enrolled to compare biological outcomes including changes in levels of inflammatory cytokines following rectal STI. Aim 1: To adapt a Personalized Cognitive Counseling (PCC) model for use with MSM in Peru. Aim 2: To adapt and pre-test the SJEI and behavioral assessment instruments for use with MSM in Peru. Aim 3: To pilot a combined HIV prevention intervention based on rectal STI counseling, testing, and treatment for MSM in Peru. Estimates of feasibility/acceptability of the intervention, GC/CT prevalence/re-infection rate and the effect on behavioral and biological mediators of HIV infection will be used to plan an R01 evaluation of rectal STI surveillance as HIV prevention for MSM in Peru.

Project Number: 5R01MH105272-03

Doxycycline Prophylaxis or Incentive Payments to Reduce Syphilis among HIV-infected Men Who Have Sex with Men

This pilot study will investigate the feasibility of conducting a large, randomized trial comparing a structural intervention to contingency management to reduce incident syphilis infections in an especially high risk group: HIV+ men who have sex with men (MSM) who have had syphilis twice or more since their HIV diagnosis. Subjects will be randomized to receive either QD doxycycline as syphilis prophylaxis or a financial incentive to remain STI free.

We will : 1) measure adherence to study visits in both arms; 2) measure adherence to the prophylaxis regimen; 3) measure any changes in risk behaviors among study participants and 4) to the extent possible in a small pilot study of short duration, compare effectiveness of doxycycline with that of a monetary incentive for remaining STI free.

Targeted Risk Group

 HIV+ men who have sex with men (MSM) who have had syphilis twice or more since their HIV diagnosis.

Intervention Model

Subjects will be randomized to receive either 1) Doxycycline, 100 mg. to be taken once daily or 2) an incentive for remaining STI free.

Local Significance 

Results of this study can be used to inform public health policy and programs to reduce risk of STI and HIV transmission among HIV+ “core transmitters,” and can also be easily extended to HIV negative MSM with repeated STIs. With the preliminary data from this study we hope to apply for further funding to support a larger, multisite definitive study incorporating one or both of the current interventions.

 

 

Comunidades Positivas “Positive Communities”

Also known as Prevention For Positives (P4P), this is a five-year, NIMH-funded study that tests two interventions  — one behavioral and one biomedical — to prevent HIV and STI (sexually transmitted infection) transmission among HIV- and/or STI-positive men who have sex with men in Lima, Peru.

This study evaluates two interventions carried-out simultaneously – one which is community-based and focuses on behavioral modification, and the other to improve access and service coverage for contacts of index cases for various sexually transmitted infections (STIs) – in order to prevent the transmission of HIV and STIs in Peru. Comunidades Positivas, the behavioral intervention, is designed to reduce the frequency of unprotected sex with non-primary partners. The biomedical intervention is designed to evaluate the effectiveness of enhanced partner therapy for incident STIs with the goal of reducing re-infection rates and therefore, incident STIs.

 

Penile Hygiene

This feasibility study investigates promotion of an existing social norm, post-coital penile cleansing, and its potential as an HIV prevention behavioral intervention.

We test participants’ ability to understand the study-specific counseling and consistently adhere to a genital hygiene regimen. One feature of this HIV prevention feasibility trial will be the ability to measure participants’ adherence to respective randomization arms by taking penile swabs before, during and at the end of the study.

If the approach proves efficacious, which would require a randomized controlled trial, it would provide an additional alternative for those men who are unwilling to undergo male circumcision and/or use condoms or reduce the number of sexual partners, but who wish to protect themselves from HIV.

Ai Shi Zi

Ai Shi Zi is a five-year NIMH-funded prevention and treatment study, the goal of which is to teach physicians how to enhance prevention and care for HIV and STIs. Because HIV and STIs are closely linked, prevention requires both state-of-the-art treatment and changes in sexual behavior. This study aims to teach physicians how to focus on both of these elements.

A total of 60 counties in China’s Anhui Province will be randomly assigned to one of two conditions: 1) primary and secondary training, in which county-level physicians are trained and, in turn, train township-level physicians; and 2) delayed-intervention control, in which physicians receive training only at the end of the 12-month assessment. Our primary endpoint is a hypothesized reduction in the one-year incidence of Chlamydia and gonorrhea among patients of trained county- and township-level physicians relative to delayed-intervention controls. Physicians and patients at the county- and township-levels will also be assessed using questionnaires at baseline and at 6 and 12 months following baseline.

Local significance (How has this project impacted the immediate population?):

This project provides training to county- and township-level physicians in Anhui Province, China and, hopefully, improved  care and treatment to their patients at risk for STIs, including HIV.

International significance (How has this project impacted the global community?):

This study may provide a useful model for training of physicians in a variety of developing country settings who care for patients at risk for STIs, including HIV.

Feasibility Study of a Community Level, Multi-Component, Intervention for Black MSM

To ascertain the feasibility and acceptability of an intervention among Black men who have sex with men (MSM), to prepare for a community-level randomized trial to test the efficacy of the intervention in reducing HIV incidence among Black MSM.

Approximately 2136 “first wave” participants (267 per site at eight sites) and approximately 400 referred partners (70 per site at six sites). There will be no limit on enrollment of participants referred by “index” participants already in the study (according to the referring scheme in the protocol). Index participants are defined later in the protocol, but can be generally described as those newly identified with HIV infection, those with previously diagnosed HIV infection who are not receiving HIV care, and certain HIV negative participants. Men enrolling for this study who have not been referred by an index participant will be called “first wave” participants. Enrollment of first wave participants will cease when 200 first wave participants eligible for longitudinal follow up have been enrolled. Enrollment of certain sub-categories of first wave participants will be limited according to criteria detailed in the protocol.

Treatment Regimen:

The intervention components provided to participants include: HIV risk-reduction counseling, testing and referral for care STI testing and referral for care Screening for substance use and mental health issues, and provision of counseling and referral for care (if indicated) Engagement with peer-health navigators to facilitate uptake of healthcare and other services Enumeration of up to 20 social and sexual network members by all participants and referral of up to 5 sexual partners by index participants for enrollment into the study

Primary Objectives:

To obtain information needed to design the full community-randomized trial, particularly in the areas of: recruitment of black MSM satisfaction of Black MSM with intervention components uptake of the intervention components by Black MSM, including: Proportion of enrolled participants who agree to HIV testing Proportion of participants who agree to STI testing Proportion of participants who utilize peer navigator referrals Proportion of HIV infected participants entering HIV care Increase in condom use in all participants from enrollment to week 52 Decrease in viral load among HIV infected participants from initiation of HAART to week 52 Decrease in STIs among all participants from enrollment to week 52

Secondary Objectives:

To collect samples, behavioral data and HIV test results to improve laboratory measures of HIV incidence based on samples derived from cross-sectional studies To estimate the HIV incidence rate and the effect of the intervention on the incidence rate through mathematical modeling To describe characteristics of sexual network members of black MSM who are newly diagnosed with HIV infection, or previously diagnosed but not in care To assess attitudes of black MSM toward other prevention interventions To describe social and sexual networks of Black MSM within cities to inform decisions about what constitutes a randomizable unit for a future trial of the intervention.

Study Sites:
• Atlanta: Emory University
• Boston: Fenway Community Health Center
• Los Angeles: University of California Los Angeles
• New York City: New York Blood Center/Harlem Hospital
• San Francisco: San Francisco Department of Public Health
• Washington DC: George Washington University

Interventions, Training Manuals, etc. :
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