HIV PreventionNCT04532307
Isisekelo Sempilo Trial to Optimize Peer (Thetha Nami) Delivery of HIV Prevention to Young People in Rural KwaZulu-Natal
A study testing SRH enhanced Isisekelo Sempilo, Peer-support (Thetha-Nami) and SOC + SRH + peer-support in people with HIV Prevention, run by Africa Health Research Institute at 1 site in South Africa.
Trial 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… Read more about this study
- Who is it for?
- Ages 16 to 29 yearsHealthy volunteers can take part
- Conditions the study is for
- HIV Prevention
- What is being tested?
- SRH enhanced Isisekelo Sempilo, Peer-support (Thetha-Nami) and SOC + SRH + peer-support
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,743 participants
- Where
- 1 siteSouth Africa
- Study dates
- 12 Mar 2020to 30 Sep 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 29 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- -
Who cannot join
- Under 16 years and above 30 years of age, unable to consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
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?"
Read the 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
- Being tested
- Standard of Care SOC, SRH enhanced Isisekelo Sempilo, Peer-support (Thetha-Nami), SOC + SRH + peer-support
- Keywords
- HIV prevention, Interventions, Peer support, sexual reproductive health
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard of Care SOCBehavioural
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 SempiloBehavioural
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)Behavioural
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-supportBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care SOC | Experimental | Youth friendly services at Isisekelo Sempilo clinics Receives: Behavioral: Standard of Care SOC |
| SRH enhanced Isisekelo Sempilo | Experimental | Self-collected vaginal and urine samples for gonorrhea, chlamydia and trichomonas Receives: Behavioral: Standard of Care SOC; Behavioral: SRH enhanced Isisekelo Sempilo |
| Peer-support (Thetha-Nami) | Experimental | Peer support and needs assessment from an area-based peer navigator Receives: Behavioral: Standard of Care SOC; Behavioral: Peer-support (Thetha-Nami) |
| SOC + SRH + peer-support | Experimental | Combination of all arms Receives: Behavioral: Standard of Care SOC; Behavioral: SRH enhanced Isisekelo Sempilo; Behavioral: Peer-support (Thetha-Nami); Behavioral: SOC + SRH + peer-support |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: 12 months after enrollment
Secondary outcomes (6)
Proportion of adolescent and youth who are HIV positive that start antiretroviral treatment
Measured as the proportion who are HIV positive who start treatment per arm; time from randomization to HIV test and treatment initiation per arm.
Measured: 12 months
Proportion of adolescent and youth who are HIV negative who start PrEP and remain negative
Measured as the proportion of those who are PrEP eligible (based on the South African PrEP eligibility criteria) who initiate PrEP when tested negative; Proportion who remain on PrEP at the end of follow-up; and proportion of new HIV diagnosis per arm
Measured: 12 months
Proportion of adolescent and youth that have poor sexual health outcome
Measured as the proportion of enrolled who have a new pregnancy and/or Sexually Transmitted Infection per arm
Measured: 12 months
Proportion of adolescents and youth that have a poor mental health outcome
Measured as the proportion screening positive for mental health outcome per arm
Measured: 12 months from enrolment
Proportion of adolescents and youth that are retained in HIV prevention or care
Measured as the Proportion attending at least 3 out of 4 followup visits (month 1, 3, 6, 9) and receiving appropriate HIV test per arm
Measured: 12 months from enrolment
Proportion of adolescents and youth that have transmissible HIV (on treatment analysis)
Measured as the proportion of participants who uptake clinical services who have detectable HIV viral load (>400 copies per ml) 12 months after enrolment per arm
Measured: 12 months from enrolment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2020
- Study start12 Mar 2020
- Primary completion30 Jun 2022
- Study completion30 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for HIV PreventionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- 2x2 factorial design
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,743 participants (actual)
Sponsor and investigators
- Lead sponsor
- Africa Health Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maryam Shahmanesh, Africa Health Research Institute
- Investigators
- Maryam Shahmanesh, PhD, Principal investigator, University College London (UCL) and Africa Health Research Institute (AHRI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04532307
- Sponsor's protocol ID
- A00004-TBC
- Status last verified
- Dec 2023
- First submitted
- 12 Mar 2020
- Last updated
- 3 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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).
Publications
Zuma T, Seeley J, Gumede D, Luthuli M, Hlongwane S, Chimbindi N, Harling G, Sherr L, Shahmanesh M. Harnessing the social capital of rural communities for adolescent and youth biosocial HIV prevention: exploring young people's experiences and perceptions of a peer navigator intervention in KwaZulu-Natal, South Africa. AIDS Care. 2026 Aug 20:1-12. doi: 10.1080/09540121.2026.2710537. Online ahead of print.
PubMed 42623136Shahmanesh 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.
PubMed 38925731Chidumwa 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.
PubMed 35255859Shahmanesh 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.
PubMed 34256725
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT04532307
- Acronym / sponsor ID
- A00004-TBC
- Conditions
- HIV Prevention
- Keywords
- HIV prevention, Interventions, Peer support, sexual reproductive health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,743 participants (actual)
- Lead sponsor
- Africa Health Research InstituteUniversity, hospital or other
- Study start
- 12 Mar 2020 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 30 Sep 2022 (actual)
- First posted
- 31 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
- Model description
- 2x2 factorial design
| Arm | Type | Receives |
|---|---|---|
| Standard of Care SOC | Experimental | Behavioral: Standard of Care SOCYouth friendly services at Isisekelo Sempilo clinics |
| SRH enhanced Isisekelo Sempilo | Experimental | Behavioral: Standard of Care SOC, Behavioral: SRH enhanced Isisekelo SempiloSelf-collected vaginal and urine samples for gonorrhea, chlamydia and trichomonas |
| Peer-support (Thetha-Nami) | Experimental | Behavioral: Standard of Care SOC, Behavioral: Peer-support (Thetha-Nami)Peer support and needs assessment from an area-based peer navigator |
| SOC + SRH + peer-support | Experimental | Behavioral: Standard of Care SOC, Behavioral: SRH enhanced Isisekelo Sempilo, Behavioral: Peer-support (Thetha-Nami), Behavioral: SOC + SRH + peer-supportCombination of all arms |
Who may qualify
- Ages
- 16 to 29 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- -
Key exclusion criteria (1 listed)
- Under 16 years and above 30 years of age, unable to consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard of Care SOCResearch 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 | Behavioural | Peer-support (Thetha-Nami), SOC + SRH + peer-support, SRH enhanced Isisekelo Sempilo, Standard of Care SOC |
| SRH enhanced Isisekelo SempiloSelf-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. | Behavioural | SOC + SRH + peer-support, SRH enhanced Isisekelo Sempilo |
| 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. | Behavioural | Peer-support (Thetha-Nami), SOC + SRH + peer-support |
| SOC + SRH + peer-supportA 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. | Behavioural | SOC + SRH + peer-support |
Primary outcome
Proportion of adolescent and youth who have transmissible HIV
Time frame: 12 months from date of recruitment
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
Proportion of adolescents and youth who uptake HIV prevention and treatment services
Time frame: 60 days
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
Proportion of adolescents and youth who agree to participate in the trial
Time frame: 12 months
Measured as proportion of those who are eligible consenting to offer of interventions who accept interventions and 12 month follow-up
Proportion of adolescents and youth from whom the outcome measure of HIV viral load can be ascertained at 12 months follow-up.
Time frame: 12 months after enrollment
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
6 secondary outcomes
Proportion of adolescent and youth who are HIV positive that start antiretroviral treatment
Time frame: 12 months
Proportion of adolescent and youth who are HIV negative who start PrEP and remain negative
Time frame: 12 months
Proportion of adolescent and youth that have poor sexual health outcome
Time frame: 12 months
Proportion of adolescents and youth that have a poor mental health outcome
Time frame: 12 months from enrolment
Proportion of adolescents and youth that are retained in HIV prevention or care
Time frame: 12 months from enrolment
Proportion of adolescents and youth that have transmissible HIV (on treatment analysis)
Time frame: 12 months from enrolment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2024.
- Derived from this study: PubMed 42623136Zuma T, Seeley J, Gumede D, Luthuli M, Hlongwane S, Chimbindi N, Harling G, Sherr L, Shahmanesh M. Harnessing the social capital of rural communities for adolescent and youth biosocial HIV prevention: exploring young people's experiences and perceptions of a peer navigator intervention in KwaZulu-Natal, South Africa. AIDS Care. 2026 Aug 20:1-12. doi: 10.1080/09540121.2026.2710537. Online ahead of print.
- Derived from this study: PubMed 38925731Shahmanesh 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.
- Derived from this study: PubMed 35255859Chidumwa 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.
- Derived from this study: PubMed 34256725Shahmanesh 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.
- Individual participant dataSharing planned: Yes. 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).
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Not yet recruiting
HC-HMP: Healthy Choices Implementation Trial
Alcohol Drinking, HIV Infections
Not yet recruitingPhase 4
NOTRE: Optimizing Long-Acting Pre-Exposure Prophylaxis and Medications for Opioid Use Disorder Interventions in Carceral Settings
HIV Infections, Opioid Use Disorder
Active, not recruitingPhase 3
Long-term Follow-up of Long-acting Cabotegravir (CAB LA) for PrEP (Pre-exposure Prophylaxis) in Participants at Risk of Acquiring HIV (Human Immunodeficiency Virus)
HIV Infections
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maryam Shahmanesh, PhD principal investigator
University College London (UCL) and Africa Health Research Institute (AHRI)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SRH enhanced Isisekelo Sempilo, Peer-support (Thetha-Nami) and SOC + SRH + peer-support in people with HIV Prevention, run by Africa Health Research Institute at 1 site in South Africa.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of adolescent and youth who have transmissible HIV (time frame: 12 months from date of recruitment). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04532307, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jan 2024.