Isisekelo Sempilo:Participant Support and Thetha Nami
South Africa, 2020 - 2022
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Reference ID
AHRI.IsisekeloSempilo.Participant.Support.and.Thetha.Nami.Datasets.V1
Producer(s)
Dr Maryam, Shahmanesh, ,
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Sep 01, 2022
Last modified
Sep 01, 2022
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Identification
Survey ID Number
AHRI.IsisekeloSempilo.Participant.Support.and.Thetha.Nami.Datasets.V1
Title
Isisekelo Sempilo:Participant Support and Thetha Nami
Country
| Name | Country code |
|---|---|
| South Africa | ZA |
Abstract
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. Study aim: The overarching goal is to arrest the HIV epidemic and reduce its negative impact on young people in SA through rapidly developing and testing the efficacy and efficiency of tailored HIV care and prevention (including PrEP and UTT) that address demand, optimise access and support adherence in adolescents and young people. Our aim in this phase of the programme is to integrate exciting advances in participatory intervention development, process evaluation and adaptive trials to explore the hypothesis that, innovative and tailored HIV prevention interventions developed with and for young people will optimize models to deliver HIV prevention and care to men and women aged 16-29 living in a high HIV incidence area of rural South Africa. We will use the pilot to optimize the intervention and understand the relative importance of the different components in supporting the uptake of HIV care, prevention and contraception.
Specific objectives for the pilot trial:
1. Measure the effectiveness of innovative and tailored HIV prevention interventions developed with young people to reduce infectious HIV in 16-29-year-old men and women in rural KZN
2. Evaluate the effectiveness and efficiency of sexually transmitted infection tests with sexual health focused HIV prevention counselling to increase uptake of HIV prevention in eligible 16-29-year-olds in rural KZN.
3. Evaluate the effectiveness and efficiency of area-based peer-navigator psychosocial support to increase uptake for HIV prevention in 16-29-year-olds in rural KZN
4. Assess the acceptability and feasibility of evaluating the effectiveness of multiple combinations of interventions on reducing infectious HIV using multi-arms within a common platform.
Specific objectives for the pilot trial:
1. Measure the effectiveness of innovative and tailored HIV prevention interventions developed with young people to reduce infectious HIV in 16-29-year-old men and women in rural KZN
2. Evaluate the effectiveness and efficiency of sexually transmitted infection tests with sexual health focused HIV prevention counselling to increase uptake of HIV prevention in eligible 16-29-year-olds in rural KZN.
3. Evaluate the effectiveness and efficiency of area-based peer-navigator psychosocial support to increase uptake for HIV prevention in 16-29-year-olds in rural KZN
4. Assess the acceptability and feasibility of evaluating the effectiveness of multiple combinations of interventions on reducing infectious HIV using multi-arms within a common platform.
Kind of Data
The type of data included in the file:survey data, cencus/enumeration data, aggregate data, clinical data, event/transaction data, program source code, machine readable text, administrative records data, experimental data, psychological test, textual data, coded textual, coded documents, time budget diaries, observation data/ratings, process-produced data, etc. No description just a single phrase, e.g., Genetic sequences
Unit of Analysis
Basic unit(s) of analysis or observation that the study describes: For PANGEA is each record a sequence from a specimen, or are there multiple records for a single specimen or study participant
Version
Version Description
V1.0.0
Scope
Keywords
| Keyword | Vocabulary | URI |
|---|---|---|
| Sexual reproductive health Sexually Transmitted infections (STI); peer navigators, social mobilisations, adaptive trial, , differentiated HIV Prevention, HIV pre-exposure prophylaxis (PrEP) | Africa Health Research Institute | www.ahri.org |
Coverage
Geographic Coverage
Demographic surveillance area of the Africa Health Research Institute; KwaZulu-Natal, uMkhanyakude district
Universe
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.
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.
Producers and sponsors
Primary investigators
| Name | Affiliation |
|---|---|
| Dr Maryam, Shahmanesh | Africa Health Research Institute |
Producers
| Name |
|---|
| Africa Health Research Institute |
Funding Agency/Sponsor
| Name | Abbreviation | Role |
|---|---|---|
| 3ie | 3ie | Funder |
| Nationational Institute of Health | NIH | Funder |
Other Identifications/Acknowledgments
| Name | Affiliation | Role |
|---|---|---|
| Jaco Dreyer | Africa Health Research Institute | Data management, cleaning and analysis |
Data Collection
Dates of Data Collection
| Start | End |
|---|---|
| 2020-03-05 | 2022-08-15 |
Access policy
Access conditions
The representative of the Receiving Organization agrees to comply with the following conditions:
1. Access to the restricted data will be limited to the Lead Researcher and other members of the research team listed in this request.
2. Copies of the restricted data or any data created on the basis of the original data will not be copied or made available to anyone other than those mentioned in this Data Access Agreement, unless formally authorized by the Data Archive.
3. The data will only be processed for the stated statistical and research purpose. They will be used for solely for reporting of aggregated information, and not for investigation of specific individuals or organizations. Data will not in any way be used for any administrative, proprietary or law enforcement purposes.
4. The Lead Researcher must state if it is their intention to match the restricted microdata with any other micro-dataset. If any matching is to take place, details must be provided of the datasets to be matched and of the reasons for the matching. Any datasets created as a result of matching will be considered to be restricted and must comply with the terms of this Data Access Agreement.
5. The Lead Researcher undertakes that no attempt will be made to identify any individual person, family, business, enterprise or organization. If such a unique disclosure is made inadvertently, no use will be made of the identity of any person or establishment discovered and full details will be reported to the Data Archive. The identification will not be revealed to any other person not included in the Data Access Agreement.
6. The Lead Researcher will implement security measures to prevent unauthorized access to licensed microdata acquired from the Data Archive. The microdata must be destroyed upon the completion of this research, unless the Data Archive obtains satisfactory guarantee that the data can be secured and provides written authorization to the Receiving Organization to retain them. Destruction of the microdata will be confirmed in writing by the Lead Researcher to the Data Archive.
7. Any books, articles, conference papers, theses, dissertations, reports, or other publications that employ data obtained from the Data Archive will cite the source of data in accordance with the citation requirement provided with the dataset.
8. An electronic copy of all reports and publications based on the requested data will be sent to the Data Archive.
9. The original collector of the data, the Data Archive, and the relevant funding agencies bear no responsibility for use of the data or for interpretations or inferences based upon such uses.
10. This agreement will come into force on the date that approval is given for access to the restricted dataset and remain in force until the completion date of the project or an earlier date if the project is completed ahead of time.
11. If there are any changes to the project specification, security arrangements, personnel or organization detailed in this application form, it is the responsibility of the Lead Researcher to seek the agreement of the Data Archive to these changes. Where there is a change to the employer organization of the Lead Researcher this will involve a new application being made and termination of the original project.
12. Breaches of the agreement will be taken seriously and the Data Archive will take action against those responsible for the lapse if willful or accidental. Failure to comply with the directions of the Data Archive will be deemed to be a major breach of the agreement and may involve recourse to legal proceedings. The Data Archive will maintain and share with partner data archives a register of those individuals and organizations which are responsible for breaching the terms of the Data Access Agreement and will impose sanctions on release of future data to these parties.
1. Access to the restricted data will be limited to the Lead Researcher and other members of the research team listed in this request.
2. Copies of the restricted data or any data created on the basis of the original data will not be copied or made available to anyone other than those mentioned in this Data Access Agreement, unless formally authorized by the Data Archive.
3. The data will only be processed for the stated statistical and research purpose. They will be used for solely for reporting of aggregated information, and not for investigation of specific individuals or organizations. Data will not in any way be used for any administrative, proprietary or law enforcement purposes.
4. The Lead Researcher must state if it is their intention to match the restricted microdata with any other micro-dataset. If any matching is to take place, details must be provided of the datasets to be matched and of the reasons for the matching. Any datasets created as a result of matching will be considered to be restricted and must comply with the terms of this Data Access Agreement.
5. The Lead Researcher undertakes that no attempt will be made to identify any individual person, family, business, enterprise or organization. If such a unique disclosure is made inadvertently, no use will be made of the identity of any person or establishment discovered and full details will be reported to the Data Archive. The identification will not be revealed to any other person not included in the Data Access Agreement.
6. The Lead Researcher will implement security measures to prevent unauthorized access to licensed microdata acquired from the Data Archive. The microdata must be destroyed upon the completion of this research, unless the Data Archive obtains satisfactory guarantee that the data can be secured and provides written authorization to the Receiving Organization to retain them. Destruction of the microdata will be confirmed in writing by the Lead Researcher to the Data Archive.
7. Any books, articles, conference papers, theses, dissertations, reports, or other publications that employ data obtained from the Data Archive will cite the source of data in accordance with the citation requirement provided with the dataset.
8. An electronic copy of all reports and publications based on the requested data will be sent to the Data Archive.
9. The original collector of the data, the Data Archive, and the relevant funding agencies bear no responsibility for use of the data or for interpretations or inferences based upon such uses.
10. This agreement will come into force on the date that approval is given for access to the restricted dataset and remain in force until the completion date of the project or an earlier date if the project is completed ahead of time.
11. If there are any changes to the project specification, security arrangements, personnel or organization detailed in this application form, it is the responsibility of the Lead Researcher to seek the agreement of the Data Archive to these changes. Where there is a change to the employer organization of the Lead Researcher this will involve a new application being made and termination of the original project.
12. Breaches of the agreement will be taken seriously and the Data Archive will take action against those responsible for the lapse if willful or accidental. Failure to comply with the directions of the Data Archive will be deemed to be a major breach of the agreement and may involve recourse to legal proceedings. The Data Archive will maintain and share with partner data archives a register of those individuals and organizations which are responsible for breaching the terms of the Data Access Agreement and will impose sanctions on release of future data to these parties.
Metadata production
DDI Document ID
DDI.AHRI.IsisekeloSempilo.Participant.Support.and.Thetha.Nami.Datasets.V1
Producers
| Name | Abbreviation |
|---|---|
| Africa Health Research Institute | AHRI |