Mhealth for Pre-exposure Prophylaxis Adherence by Young Adult MSM
Condition: Hiv
Study type: Interventional

Summary: 
      The proposed project involves the development and testing of an mhealth intervention to
      increase adherence to PrEP treatment using texts providing tailored pill reminders,
      motivational messages, and health education messages. The intervention targets
      culturally-diverse young adult men who have sex with men (YMSM), who are at high risk for
      both HIV and non-adherence to PrEP medication. Supporting PrEP adherence would help reduce
      new HIV infections in this group.
    

Detailed description: 
      Specific Aims: Pre-exposure prophylaxis (PrEP) treatment greatly reduces HIV risk. When the
      PrEP pill (Truvada) is taken daily, it can reduce HIV risk up to 92%. NIH has designated
      reducing HIV/AIDS as a high-priority topic for research support using AIDS-designated funds.
      Among other groups, the CDC recommends PrEP for men who have sex with men (MSM) who are
      HIV-negative and in a relationship with an HIV+ partner, and MSM who have had anal sex
      without a condom or have been diagnosed with an STD in the past 6 months; about 1 in 4 MSM
      meet these criteria. Young people, age 13-29, accounted for 27% of new HIV cases in 2009. The
      highest concentration of new cases was among 20-29-year olds; 70% of these were MSM.
      Disparities are pronounced: 57% of new HIV cases reported in 2008-2010 were among African
      American MSM; 21% of cases were young Latino MSM. In PrEP trials to date, adherence has been
      generally low. Across these trials, younger age was the most consistent factor associated
      with lower PrEP adherence. Medication adherence can be difficult for young people. While
      young adults better comprehend benefits of prevention than teens, decision-making maturity is
      still developing through the 20s. It is not until the late 20s that two brain systems, one
      that spurs sensation-seeking and one that undergirds self-regulation and planning ahead,
      become integrated. Males may lag behind females in this regard. Furthermore, this
      developmental process can be hampered for those who have experienced the stress of
      victimization as have many MSM. PrEP adherence interventions for young adult MSM (YMSM) must
      take into account developmental factors that can affect decision-making. CDC strongly
      encourages PrEP prescribers to offer adherence support; foundational to that support is
      patient education. CDC also suggests adherence plans: 1) individually tailor dosing time 2)
      use pill reminders 3) use supports to address changes in routine and 4) consider disclosure
      issues, i.e. help patients identify social network members who can support adherence or ways
      to overcome adherence barriers due to lack of social disclosure. To date, no PrEP adherence
      intervention has been developed specifically for YMSM, despite increasing HIV rates in this
      group and their increased risk for non-adherence. High rates of texting by young adults,
      coupled with strong evidence base that text reminders can improve adherence, point to mobile
      health (mhealth) as an ideal way to support PrEP adherence among YMSM.

      The goal of the proposed SBIR is to develop and test the feasibility and short-term
      effectiveness of an individually-tailored, developmentally- and culturally-sensitive mhealth
      PrEP adherence intervention for culturally-diverse YMSM. Its scientific premise rests on
      three large well-conducted adherence follow-up studies to PrEP efficacy trials, i.e. VOICE,
      FEM-PrEP, and iPrEx, which identified adherence facilitators/barriers being targeted in the
      proposed study, and on meta-analyses of a large and growing literature pointing to the
      effectiveness of mhealth for medication adherence across chronic conditions, including HIV.
      The intervention will be modeled on Dr Patricia Weitzman's (proposed PI) SBIR Phase 1 and 2
      mhealth anti-retroviral therapy (ART) adherence intervention for HIV+ African Americans. That
      intervention employed a three-pronged approach of tailored pill reminders with age- and
      culturally-sensitive motivational and educational texts. Texts were designed to increase ART
      self-efficacy, and based on principles from social learning theory and positive psychology.
      Using a similar approach, formative research will be conducted to create motivational and
      educational texts that are culturally- and developmentally-sensitive for diverse YMSM.
      Moreover, formative research will allow us to identify and target unique PrEP adherence
      barriers and facilitators among culturally-diverse YMSM. Findings will be used to create and
      pilot a 6-week randomized mhealth PrEP adherence intervention addressing adherence barriers
      and facilitators identified in PrEP RCTs, and our formative research, as well as CDC PrEP
      adherence recommendations. Our long-term goal is to reduce HIV infection rates among
      culturally-diverse YMSM by supporting PrEP adherence.

      Specific Aim 1: Develop a individually-tailored, culturally- and developmentally-sensitive
      mhealth intervention to promote adherence to PrEP among YMSM, ages 20-29. Aim 2: Implement
      6-week pilot randomized controlled trial to evaluate short-term effectiveness (did it improve
      PrEP adherence, PrEP knowledge and PrEP treatment self- efficacy). CONSORT guidelines for the
      RCT will be followed in order to ensure scientific rigor. Primary Hypothesis: Young adult MSM
      who receive tailored daily pill reminder plus motivational/ educational texts for 6 weeks
      will show greater PrEP adherence compared to controls. Secondary Hypothesis: Young adult MSM
      who receive tailored daily pill reminder plus motivational/educational texts for 6 weeks will
      show greater PrEP knowledge and PrEP treatment self-efficacy compared to controls. Aim 3:
      Evaluate feasibility of the intervention, e.g. implementation fidelity (to what extent was
      intervention delivered as planned), program appeal (how well did participants like the
      intervention) and program reach (how well did it reach participants). CDC estimates PrEP is
      appropriate for the roughly 500,000 MSM in the US. Impact models show even modest adherence
      to PrEP could reduce new HIV infections among MSM by 29% over 20 years. An mhealth PrEP
      adherence tool targeting young adult MSM, a group experiencing increased HIV incidence, could
      not only support that reduction but-due to easy access and low cost-actually improve upon it.
    

Intervention name(s): PrEP medication adherence mobile app
Intervention type(s): Behavioral
Intervention description(s): Participants use a PrEP medication adherence mobile app for six weeks.
Intervention model: Single Group Assignment
Intervention model description: pre-post test evaluation of the impact of a mobile app on PrEP treatment adherence
Masking: None (Open Label)
Primary purpose: Prevention