Isisekelo Sempilo:Participant Support and Thetha Nami

We conducted a 2x2 factorial design intervention pilot trial including 1743 men and women aged 16-29-years old and living in the AHRI surveillance area. The study duration was 29 months. For our primary outcomes of interest, we assessed uptake of comprehensive HIV prevention services, including Pre-Exposure Prophylaxis (PrEP) and Universal Test and Treat (UTT) and the reduction of the proportion of individuals at a population level with infectious HIV (population viral load).

At enrolment following informed consent participants were randomised to

Enhanced Standard of Care (SOC) - Clinic-based initiation and follow-up with standard HIV prevention and treatment package: All enrolled participants, irrespective of arm were provided with a barcoded referral slip and an appointment time to attend a clinic of their choice. Clinical services are provided by study nurses in two primary health clinics (PHC) situated in a busy commercial area with adolescent and youth friendly services, and two mobile clinics that visit fixed sites across the more remote areas of the AHRI surveillance area once every 2 weeks. All clinic attendees (irrespective of trial arm) were offered HIV counselling and Point-of-Care Testing (PoCT), and immediate initiation of ART if positive or PrEP if negative and eligible according to South African National PrEP guidelines. This is followed by a telephone follow-up at day 7, and months 1, 2, 6, 9 and 12 for repeat HIV testing (if on PrEP), laboratory HIV viral load or ELISA confirmation if needed, safety bloods, clinic-based counselling and adherence support and PrEP/ART refills (BFC311/18). Clinic attendees were also offered family planning support and syndromic management for STIs and, if male, referral to voluntary male medical circumcision (VMMC), as per South African National Department of Health Guidelines.

Intervention 1 - Thetha Nami peer navigator support: participants who were randomised to this intervention were offered the support of a named pair of Thetha Nami peer-navigators who work in their area. Thetha Nami are area-based men and women aged 18-30 years, post matriculation, who are employed to provide a package of health and social support to young people aged 16-29 years living in their areas. Under Thetha Nami peer navigator support, participants were provided with information about the peer navigator team that are allocated to their area, and informed that unless they object their contact details (name, phone number and place of residence) would be passed onto the named peer navigators who would be attempting to contact them within 7 days. If they agreed, the details of the peer navigator were entered into the REDCAP survey on the tablet and the participant details were electronically shared with the peer navigator. The peer navigators then contacted them within 7 days and provided them with any support they required including supporting them to access the clinical service they have been referred to. They used a brief service recipient questionnaire that was completed within REDCAP on a tablet to identify the participants needs and services required, including the clinical service they are allocated to and the support needed. The peer navigators provided ongoing support to the participants randomised to them following enrolment and until the endline survey was completed.

Intervention 2 - Isisekelo Sempilo with SRH: Participants who were randomised to this intervention provided samples for sexually transmitted infections (STI) testing at enrolment. In practice this meant that females provided 3-4 self-taken vaginal samples or first catch urine and men provided first catch urine. These samples were then sent to AHRI laboratories to be processed for gonorrhoea and chlamydia and trichomonas. Participants were provided with a clinic appointment at a study clinical of their choosing (see enhanced SoC above) in 7 days to receive the results of their STI tests. They were informed that if they default the appointment and any of the results are positive a nurse or research assistant will attempt to contact them by phone or in person to ensure that they and their partners receive the appropriate therapy to treat the infection. During the clinic appointment they received counselling around sexual health, fertility intention, contraception, HIV counselling and testing as part of sexual health counselling with PrEP to stay negative and ART in the context of staying well and Undetectable = Uninfectious (U=U). They will also receive aetiological treatment and partner notification if any of the STI or HIV results are positive. In addition to the SOC procedures, 3-monthly follow-up and adherence support in this arm included HIV viral load-based U=U and adherence counselling before PrEP/ART refills.

Over a period of 12 months after enrolment randomisation we collected routine data on uptake of Thetha Nami and Clinical Services as well as adverse events. At 12 months after enrolment we approached all those who consented at endline by phone, in their homes or wherever they preferred to be seen. Following Informed Consent, we conducted a brief redcap survey to collect information on uptake and experience of HIV prevention and care services, uptake of contraception and incidence of pregnancy, mental health (using PHQ9), and quality of life. We also offered point of care HIV testing and linkage to care, collect dry blood spot for HIV ELISA and HIV viral load, and offered STI testing and treatment to all. In addition, we conducted a mixed-method process evaluation to collect data on uptake and retention and fidelity of each component of the intervention; assess service users and providers and the community experience, i.e. which facets of the package are valued; and any social harms. A costing analysis will be undertaken to establish the cost of delivering the intervention through the different models of care.