Retention in PrEP Care for African American MSM in Mississippi
Condition: Preventive Medicine; HIV Infections
MeSH terms: HIV Infections
Study type: Interventional

Summary: 
      Innovative and novel HIV prevention interventions are urgently needed for African American
      (AA) young men who have sex with men (YMSM) in the South, and in Mississippi in particular.
      HIV pre-exposure prophylaxis (PrEP) is a newer HIV prevention strategy that consists of a
      daily oral antiretroviral pill taken on an ongoing basis by HIV-uninfected but at-risk
      individuals. Although acceptability studies have demonstrated high interested in PrEP in the
      US, uptake remains limited. To date, studies of PrEP initiation have largely been limited to
      settings in which PrEP is provided free of charge. Barriers to PrEP initiation and retention
      in PrEP care in real world settings are likely more complex, since payment for PrEP can be a
      substantial financial burden.

      The ADAPT_ITT approach (an approach to adapting behavioral interventions to new populations:
      Assessment, Decision, Administration, Production, Topical Experts - Integration, Training,
      Testing) will be used to develop and pilot test a RAMP (Retain African American Men in PrEP)
      intervention that aims to promote PrEP adherence and retention in care in Jackson, MS and
      focuses on recruiting AA YMSM in a city with some of the highest HIV infection rates in the
      country. This study will include formative research to understand the cultural and social
      contexts that influence AA YMSM's PrEP use patterns and the acceptability of our proposed
      intervention. Results from these qualitative interviews will inform the study intervention
      which will be tested and refined in a dynamic open pilot evaluation.
    

Detailed description: 
      Men who have sex with men (MSM) bear a disproportionate burden of the HIV epidemic in the
      United States (US), and the number of new HIV diagnoses among MSM is increasing every year.
      Despite HIV incidence remaining relatively stable overall, HIV incidence is increasing among
      MSM, and among Black/African American (hereafter AA) young MSM (YMSM) in particular. Black/AA
      MSM represent less than 1% of the population but account for 25% of new HIV diagnoses.
      Compared to MSM of other races, AA MSM are 3 times more likely to be HIV infected. Among
      YMSM, the disparities are greatest; AA MSM aged 20-29 have an HIV prevalence of 34%, whereas
      White MSM in the same age range have an HIV prevalence of 5.5%. Additionally, the American
      South accounts for 46% of new HIV diagnoses in the US and 45% of new AIDS diagnoses.
      Mississippi is ranked 7th in the country in HIV case rates, with an overall rate of 20.7 per
      100,000 persons; however, some census tracts have rates of 2-5%, which is comparable to some
      sub-Saharan African countries. There are alarming racial disparities related to HIV/AIDS; in
      Mississippi, AAs comprise 37% of the population but accounted for 76% of HIV infection
      reported in 2013. Between 2011 and 2013, the number of infections among MSM in Mississippi
      increased 43%, with an even sharper increase among AA YMSM, who have among the highest rates
      of infection in the nation.

      Given the disproportionate burden of HIV, worse HIV outcomes, and current social climate,
      innovative and novel HIV prevention interventions are urgently needed for AA YMSM in the
      South, and in Mississippi in particular. HIV pre-exposure prophylaxis (PrEP) is a newer HIV
      prevention strategy that consists of a daily oral antiretroviral pill taken on an ongoing
      basis by HIV-uninfected but at-risk individuals. Its efficacy has been well established in
      randomized controlled trials and open-label studies for MSM and other groups. Although
      acceptability studies have demonstrated high interest in PrEP in the US, uptake remains
      limited. To date, studies of PrEP initiation have largely been limited to settings in which
      PrEP is provided free of charge. Barriers to PrEP initiation and retention in PrEP care in
      real world settings are likely more complex, since payment for PrEP can be a substantial
      financial burden. Although most health insurance programs are covering the cost of PrEP, and
      the industry-sponsored PrEP Medication Assistance Program exists to assist people who do not
      have insurance, these programs require patient and clinician awareness, sufficient staffing
      and appropriate infrastructure.

      A body of evidence is only beginning to emerge related to PrEP adherence and little is known
      about retention in PrEP care, most of which is in the context of either RCTs or open-label
      studies in which PrEP is provided free of charge. The efficacy of PrEP is closely tied to
      adherence, and evidence suggests that efficacy decreases exponentially with fewer doses of
      PrEP per week; maximum efficacy is achieved when 6-7 doses are taken per week, but PrEP
      provides high protection with at least 4 doses per week. In an open label study of PrEP
      uptake and adherence in MSM, 71% of participants receiving PrEP had drug detected after
      initiation of PrEP. AA YMSM in Jackson, MS face many challenges to optimal adherence and
      retention in care, including inconsistent routines, socioeconomic challenges, and logistical
      difficulty in returning for follow-up visits. MSM may not want to disclose use of PrEP to
      family or friends, due to the potential for unintended disclosure of sexual orientation,
      which may result in reduced social support for PrEP adherence or returning for care.
      Understanding barriers and facilitators to adherence and retention in care for AA YMSM, and
      subsequently the development of interventions to improve them, will be necessary to ensure
      maximum PrEP effectiveness.

      The ADAPT_ITT approach will be used to develop and pilot test a RAMP intervention that aims
      to promote PrEP adherence and retention in care in Jackson, MS and focuses on recruiting AA
      YMSM in a city with some of the highest HIV infection rates in the country. This study will
      include formative research to understand the cultural and social contexts that influence AA
      YMSM's PrEP use patterns and the acceptability of our proposed intervention. Results from
      these qualitative interviews will inform the study intervention which will be tested and
      refined in a dynamic open pilot evaluation.

      Qualitative interviews (Phase 1) will "assess" individual, interpersonal and structural
      contexts of sexual risk behavior, anticipated adoption and use of new prevention
      technologies, barriers and facilitators to PrEP initiation and adherence, and optimal content
      and format for a PrEP initiation and adherence intervention. Using results of the qualitative
      interviews and input from key opinion leaders, the investigators will "decide" on
      intervention components and structure of the intervention package. The investigators will
      then "adapt" the Life-Steps intervention to be responsive to the unique context and complex
      needs of AA YMSM in Jackson, and "produce" a draft of the intervention manual. Our study team
      is made up of "topical experts" who will all have a central role in developing the
      intervention manual. Moreover, the open pilot evaluation (Phase 2) will be used to obtain
      further input on the draft intervention manual and protocol. After "integrating" the feedback
      obtained from the open pilot evaluation and exit interviews into the intervention manual and
      protocol, study staff will be "trained" in all final study procedures, and a provisional
      theory-based intervention to overcome barriers to PrEP adherence and retention, and reduce
      sexual risk behavior, among AA YMSM will be "tested" in a pilot Randomized Control Trial
      (RCT) (Phase 3). This intervention will have broad generalizability for AA YMSM across the
      South and the country as PrEP programs expand nationwide.
    

Intervention name(s): RAMP PrEP initiation, adherence, and retention intervention
Intervention type(s): Behavioral
Intervention description(s): The intervention arm will receive facilitated strengths-based case management (SBCM)-delivered by trained interventionists-to help navigate the PrEP medical care system and support the participant and health care staff in meeting the challenges faced with obtaining PrEP medication (e.g., overcoming insurance barriers or barriers with co-pays). This also includes facilitated integration into the PrEP clinic and obtaining monthly PrEP prescription refills.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention