Isisekelo Sempilo:Clinical Management Datasets
South Africa, 2020 - 2022
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AHRI.IsisekeloSempilo.Clinical.Management.Datasets.v2.0
Isisekelo Sempilo:Clinical Management Datasets
| Name | Country code |
|---|---|
| South Africa | ZA |
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:
- 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
- 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.
- 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
- 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.
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
V2.0.0
Scope
| Topic | Vocabulary | URI |
|---|---|---|
| HIV prevention, sexual reproductive health, peer navigators, adaptive trial, homebased STI testing | Africa Health Research Institute | www.ahri.org |
Coverage
Demographic surveillance area of the Africa Health Research Institute; KwaZulu-Natal, uMkhanyakude district
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. For our primary outcomes of interest, we will assess 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).
Over a period of 12 months after randomisation we will collect routine data on uptake of Thetha Nami and Clinical Services as well as adverse events. At 12 months we will approach all those who consented at baseline by phone, in their homes or wherever they prefer to be seen. Following Informed Consent we will conduct 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 will also offer point of care HIV testing and linkage to care, collect dry blood spot for HIV ELISA and HIV viral load, and offer STI testing and treatment to all. In addition, we will conduct 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. Finally, a costing analysis will be undertaken to establish the cost of delivering the intervention through the different models of care.
Producers and sponsors
| Name | Affiliation |
|---|---|
| Dr Maryam, Shahmanesh | Africa Health Research Institute |
| Name |
|---|
| Africa Health Research Institute |
| Name | Role |
|---|---|
| 3ie | Funder |
| Nationational Institute of Health | Funder |
| Name | Affiliation | Role |
|---|---|---|
| Jaco Dreyer | Africa Health Research Institute | Data management, cleaning and analysis |
Sampling
Research assistants will approach n=3000 16-29-year old males and females selected from the demographic surveillance area at their homesteads. We expect that 2000 will still be eligible, i.e. aged 16-29 and still living in the surveillance area. Research assistants will provide information about the study to all eligible participants and consent them to the random offer of HIV or sexual health interventions and follow-up with a survey and HIV testing at 12 months. We anticipate that n=1500 [75% (73-77%)] will consent to participate.
Data collection
| Start | End |
|---|---|
| 2020-03-05 | 2022-07-04 |
Data Access
The representative of the Receiving Organization agrees to comply with the following conditions:
- Access to the restricted data will be limited to the Lead Researcher and other members of the research team listed in this request.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- An electronic copy of all reports and publications based on the requested data will be sent to the Data Archive.
- 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.
- 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.
- 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.
- 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.AHRI.IsisekeloSempilo.Clinical.Management.Datasets.v2.0
| Name |
|---|
| Africa Health Research Institute |