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

NCT ID: NCT04532307

Last Updated: 2024-01-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 1743 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-03-12
• Study Completion Date: 2022-09-30

Brief 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.

Conditions

HIV Prevention

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Standard of Care SOC

Youth friendly services at Isisekelo Sempilo clinics

Group Type: EXPERIMENTAL

Standard of Care SOC

Intervention Type: BEHAVIORAL

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

SRH enhanced Isisekelo Sempilo

Self-collected vaginal and urine samples for gonorrhea, chlamydia and trichomonas

Group Type: EXPERIMENTAL

Standard of Care SOC

Intervention Type: BEHAVIORAL

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

SRH enhanced Isisekelo Sempilo

Intervention Type: BEHAVIORAL

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.

Peer-support (Thetha-Nami)

Peer support and needs assessment from an area-based peer navigator

Group Type: EXPERIMENTAL

Standard of Care SOC

Intervention Type: BEHAVIORAL

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

Peer-support (Thetha-Nami)

Intervention Type: BEHAVIORAL

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.

SOC + SRH + peer-support

Combination of all arms

Group Type: EXPERIMENTAL

Standard of Care SOC

Intervention Type: BEHAVIORAL

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

SRH enhanced Isisekelo Sempilo

Intervention Type: BEHAVIORAL

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.

Peer-support (Thetha-Nami)

Intervention Type: BEHAVIORAL

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.

SOC + SRH + peer-support

Intervention Type: BEHAVIORAL

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.

Interventions

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

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

-

Exclusion Criteria

• Under 16 years and above 30 years of age, unable to consent

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 29 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Africa Health Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Maryam Shahmanesh

Associate Professor of Clinical Epidemiology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Maryam Shahmanesh, PhD

Role: PRINCIPAL_INVESTIGATOR

University College London (UCL) and Africa Health Research Institute (AHRI)

Locations

AHRI

uMkanyakude, KwaZulu-Natal, South Africa

Countries

South Africa

References

Shahmanesh M, Chimbindi N, Busang J, Chidumwa G, Mthiyani N, Herbst C, Okesola N, Dreyer J, Zuma T, Luthuli M, Gumede D, Hlongwane S, Mdluli S, Msane S, Smit T, Molina JM, Khoza T, Behuhuma NO, McGrath N, Seeley J, Harling G, Sherr L, Copas A, Baisley K. Effectiveness of integrating HIV prevention within sexual reproductive health services with or without peer support among adolescents and young adults in rural KwaZulu-Natal, South Africa (Isisekelo Sempilo): 2 x 2 factorial, open-label, randomised controlled trial. Lancet HIV. 2024 Jul;11(7):e449-e460. doi: 10.1016/S2352-3018(24)00119-X.

Reference Type: DERIVED

PMID: 38925731 (View on PubMed)

Chidumwa G, Chimbindi N, Herbst C, Okeselo N, Dreyer J, Zuma T, Smith T, Molina JM, Khoza T, McGrath N, Seeley J, Pillay D, Tanser F, Harling G, Sherr L, Copas A, Baisley K, Shahmanesh M. Isisekelo Sempilo study protocol for the effectiveness of HIV prevention embedded in sexual health with or without peer navigator support (Thetha Nami) to reduce prevalence of transmissible HIV amongst adolescents and young adults in rural KwaZulu-Natal: a 2 x 2 factorial randomised controlled trial. BMC Public Health. 2022 Mar 7;22(1):454. doi: 10.1186/s12889-022-12796-8.

Reference Type: DERIVED

PMID: 35255859 (View on PubMed)

Shahmanesh M, Okesola N, Chimbindi N, Zuma T, Mdluli S, Mthiyane N, Adeagbo O, Dreyer J, Herbst C, McGrath N, Harling G, Sherr L, Seeley J. Thetha Nami: participatory development of a peer-navigator intervention to deliver biosocial HIV prevention for adolescents and youth in rural South Africa. BMC Public Health. 2021 Jul 13;21(1):1393. doi: 10.1186/s12889-021-11399-z.

Reference Type: DERIVED

PMID: 34256725 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Other Identifiers

A00004-TBC

Identifier Type: -

Identifier Source: org_study_id