Isisekelo Sempilo Trial to Optimize Peer (Thetha Nami) Delivery of HIV Prevention to Young People in Rural KwaZulu-Natal
Isisekelo Sempilo: HIV Prevention Embedded in Sexual Health: A Pilot Trial to Optimize Peer (Thetha Nami) Delivery of HIV Prevention and Care to Adolescents and Young Adults in Rural KwaZulu-Natal.
1 other identifier
interventional
1,743
1 country
1
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?"
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2020
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 12, 2020
CompletedStudy Start
First participant enrolled
March 12, 2020
CompletedFirst Posted
Study publicly available on registry
August 31, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2022
CompletedJanuary 3, 2024
December 1, 2023
2.3 years
March 12, 2020
December 29, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Proportion of adolescent and youth who have transmissible HIV
Measured as the proportion of participants who consent to participate with a detectable HIV viral load (\>400 copies per ml) 12 months after enrolment per arm
12 months from date of recruitment
Proportion of adolescents and youth who uptake HIV prevention and treatment services
Measured as the proportion of participants who consent who link to clinical services for HIV testing and PrEP/ART counselling within 60 days per arm
60 days
Proportion of adolescents and youth who agree to participate in the trial
Measured as proportion of those who are eligible consenting to offer of interventions who accept interventions and 12 month follow-up
12 months
Proportion of adolescents and youth from whom the outcome measure of HIV viral load can be ascertained at 12 months follow-up.
Measured as the proportion of all those enrolled that provide dry blood spots for the measurement of HIV (i.e. proportion with an HIV viral load \>400 copies per ml) in \>75% of those who enrolled at baseline irrespective of engagement in any intervention
12 months after enrollment
Secondary Outcomes (6)
Proportion of adolescent and youth who are HIV positive that start antiretroviral treatment
12 months
Proportion of adolescent and youth who are HIV negative who start PrEP and remain negative
12 months
Proportion of adolescent and youth that have poor sexual health outcome
12 months
Proportion of adolescents and youth that have a poor mental health outcome
12 months from enrolment
Proportion of adolescents and youth that are retained in HIV prevention or care
12 months from enrolment
- +1 more secondary outcomes
Other Outcomes (2)
Process evaluation
18 months
Costings
18 months
Study Arms (4)
Standard of Care SOC
EXPERIMENTALYouth friendly services at Isisekelo Sempilo clinics
SRH enhanced Isisekelo Sempilo
EXPERIMENTALSelf-collected vaginal and urine samples for gonorrhea, chlamydia and trichomonas
Peer-support (Thetha-Nami)
EXPERIMENTALPeer support and needs assessment from an area-based peer navigator
SOC + SRH + peer-support
EXPERIMENTALCombination of all arms
Interventions
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.
Eligibility Criteria
You may not qualify if:
- Under 16 years and above 30 years of age, unable to consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
AHRI
uMkanyakude, KwaZulu-Natal, South Africa
Related Publications (3)
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.
PMID: 38925731DERIVEDChidumwa 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.
PMID: 35255859DERIVEDShahmanesh 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.
PMID: 34256725DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Maryam Shahmanesh, PhD
University College London (UCL) and Africa Health Research Institute (AHRI)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- single blind
- Purpose
- PREVENTION
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor of Clinical Epidemiology
Study Record Dates
First Submitted
March 12, 2020
First Posted
August 31, 2020
Study Start
March 12, 2020
Primary Completion
June 30, 2022
Study Completion
September 30, 2022
Last Updated
January 3, 2024
Record last verified: 2023-12
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
- Time Frame
- Data will be available once the primary outcome has been analysed and accepted for publication. We will deposit anonymised IPD data relevant to the analysis in an open access repository at the time of publication.
- Access Criteria
- The PI and AHRI data guardian will be responsible for overseeing requests for data sharing and that the researchers granted access to the data comply with the terms of the data sharing agreement, which will include honouring any commitments about the use of the data that have been made to participants at the time they granted consent. Researchers will be required to acknowledge the source of the data. The terms will also prohibit researchers attempting to identify participants of the study.
After study completion data will be stored in Africa Health Research Institute (AHRI) Secure and Safe Data Storage facilities. Data are stored in a database. The database server is located in a secure computer room at the AHRI to which access is restricted to only a few IT professionals. The database is part of the AHRI's Local Area Network, which is protected from outside by a firewall. On the database, the data are stored in MS-SQL Server databases, and access to these is heavily restricted using the features of MS-SQL Server's security subsystem. The AHRI premises are completely surrounded by an electric fence and guarded by a professional security company, 24 hours per day seven days per week. The PI and AHRI data guardian will be responsible for overseeing requests for data sharing. (see below).