Isisekelo Sempilo Trial to Optimize Peer (Thetha Nami) Delivery of HIV Prevention to Young People in Rural KwaZulu-Natal

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?"

Conditions

• HIV Prevention

Interventions

BEHAVIORAL

Standard of Care SOC

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

BEHAVIORAL

SRH enhanced Isisekelo Sempilo

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.

BEHAVIORAL

Peer-support (Thetha-Nami)

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.

BEHAVIORAL

SOC + SRH + peer-support

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.

Sponsors & Collaborators

• Africa Health Research Institute

  lead OTHER

Principal Investigators

• Maryam Shahmanesh, PhD · University College London (UCL) and Africa Health Research Institute (AHRI)

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Model

FACTORIAL

Eligibility

Min Age

16 Years

Max Age

29 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2020-03-12

Primary Completion

2022-06-30

Completion

2022-09-30

Countries

• South Africa