Isisekelo Sempilo Trial to Optimize Peer (Thetha Nami) Delivery of HIV Prevention to Young People in Rural KwaZulu-Natal
Condition: HIV Prevention
MeSH terms: Acquired Immunodeficiency Syndrome
Study type: Interventional

Summary: 
      Despite advances in efficacious, efficient and safe biomedical tools to reduce HIV
      transmission and acquisition the HIV epidemic in South Africa(SA) remains an intractable
      problem, with the lifetime risk of infection approaching 70% for a 15-year-old girl currently
      living in northern KwaZulu-Natal, the Africa Health Research Institute(AHRI) research
      setting. This is in part due to the difficulty in engaging adolescents and youth in HIV
      interventions. We build on formative work to develop and tailor the interventions to young
      people's needs. Our findings suggested that young people want to focus on sexual and
      reproductive health(SRH) and value health-promotion from people of their own age and
      background (peer-support). In a 2016 population-based study of 15-24-year-olds in the study
      area we found that one in five had a curable Sexually Transmitted Infection(STI) of which
      three quarters of did not report any symptoms and would not have been cured with current
      syndromic management. We also found that home-based self-sampling and treatment for STIs was
      acceptable and desirable to young people. Based on this we developed and conducted a 6-month
      pilot of the Isisekelo Sempilo adolescent and youth friendly clinics. These are mobile and
      fixed clinics that are linked to existing primary care services. The clinics deliver
      nurse-led HIV-testing, prevention and care integrated with SRH. To date n=337 of those
      referred from the community(~10%) have attended the clinic. In our setting >85% of
      school-leavers are unemployed; there are high levels of common mental disorders which
      increase with age (rising to 32% of those aged 20-22). Systematic reviews have found that
      community-based delivery of HIV care and peers are effective in supporting HIV care,
      adherence and virologic suppression. However, none of these interventions have been tested
      for HIV-prevention and in youth. Based on this we developed and piloted Thetha Nami, an
      area-based peer-navigator intervention promoting psychosocial well-being in addition to
      HIV-prevention to young people aged 15-29. Over a four-month period 24-pairs of peer
      navigators approached 5872, 15-29-year-old men and women, of which 5272 (90%) accepted the
      needs assessment. We aim to use advances in intervention design and evaluation to answer the
      question, "will these tailored HIV-prevention interventions developed in partnership with
      young people arrest the HIV epidemic and improve well-being?"
    

Detailed description: 
      Study design: We will conduct a 2x2 factorial design intervention pilot trial including 1500
      men and women aged 16-29-years old and living in the AHRI surveillance area. The study
      duration will be 18 months. We will randomly offer one of four combinations of interventions
      in a factorial trial to 1500 consenting men and women aged 16-29-years old and living in our
      study area.

      Study outcomes: (1) a reduction of the proportion of individuals with infectious HIV (i.e.
      remaining HIV negative or with an undetectable HIV viral load on treatment if positive) and
      (2) uptake of comprehensive HIV prevention services, including Pre-Exposure Prophylaxis
      (PrEP) if negative and antiretroviral (ART) if positive. We will also evaluate uptake of
      contraception, incidence of pregnancy, mental health and quality of life.

      Study Population and Recruitment: Research assistants (RAs) will approach 3000 randomly
      selected 16-29-year old males and females selected from our demographic surveillance area in
      their homes. From our experience we expect that 2000 will still be eligible, i.e. aged 16-29
      and still living in the surveillance area. RAs will provide information about the study to
      all eligible participants and consent (in the case of 16-17-year-olds assent with parental
      consent) them to a) be offered an intervention and b) to be followed up at 12 months to
      measure the outcome. We anticipate that n=1500 [75% (73-77%)] will consent to participate.

      Interventions: a) Standard of Care (SOC): RAs refer participants to adolescent and youth
      friendly services with family planning, HIV testing and ART if positive and PrEP for those
      eligible and negative (according to the South African national Department of Health
      guidelines); b) SRH enhanced arm (Isisekelo Sempilo): Self-collected vaginal and urine
      samples are collected at enrolment. RAs provide clinic appointment for results, treatment and
      sexual health promotion and services. These promote fertility and family planning; HIV
      testing, and benefits of ART including Undetectable=Uninfectious amongst positives and PrEP
      for those eligible and negative; c) Peer-support (Thetha-Nami): RAs refer the participant to
      a peer navigator in their community. Peer navigators will assess their health, social and
      educational needs, provide mentorship, and help them access the services they need. The peer
      navigator will facilitate attendance, adherence and retention at the clinic; or d) SRH +
      peer-support.

      Data Collection: We will measure linkage to clinical services within 60 days of randomisation
      and adverse events. At 12 months from enrolment RAs will approach all those who consented at
      baseline to conduct a tablet-based survey on uptake of HIV prevention and care services,
      uptake of contraception and pregnancy, mental health (using PHQ9), and quality of life. They
      will collect dry blood spot for HIV ELISA and HIV viral load, and offer point of-care HIV
      testing, STI testing and treatment. We will conduct a process evaluation to assess service
      users and providers and the community experience and any social harms. We will establish the
      cost of delivering the intervention in each arm.

      Analysis: With n=1500 we have the power to show an increase in linkage to clinical services
      from 10% in SOC to 22% with peer-support or SRH only and 38% with peer-support and SRH. We
      also have the power to detect a reduction in the proportion of 16-29-year olds with a
      detectable HIV viral load from 7% to 3.5% at 12 months.
    

Intervention name(s): Standard of Care SOC; SRH enhanced Isisekelo Sempilo; Peer-support (Thetha-Nami); SOC + SRH + peer-support
Intervention type(s): Behavioral; Behavioral; Behavioral; Behavioral
Intervention description(s): Research assistants refer the consenting participants to Isisekelo Sempilo adolescent and youth friendly services with HIV testing, treatment if positive and PrEP eligibility screening and offer if negative and family planning; Self-collected vaginal and urine samples are collected at enrolment. Research assistants then provide an Isisekelo Sempilo clinic referral appointment for results, treatment, HIV testing, sexual health, fertility, and family planning counselling, including the personal benefits of ART and Undetectable=Uninfectious among those infected, and PrEP for those eligible and who are negative.; The research assistants refer the participant to a Thetha Nami peer-navigator in their community. Peer navigators will assess their health, social and educational needs, provide mentorship, and help them access the services they need. The peer navigator will facilitate attendance, adherence and retention at the Isisekelo Sempilo clinic.; A combination of interventions 2 and 3, to include both self-collected STI testing, nurse led testing and counseling, and referral to a Thetha Nami peer navigator to encourage clinic attendance and sexual health promotion.
Allocation: Randomized
Intervention model: Factorial Assignment
Intervention model description: 2x2 factorial design
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: HIV prevention; Interventions; Peer support; sexual reproductive health