Thetha Nami ngithethe nawe (Let’s Talk):Baseline Survey
South Africa, 2022
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Reference ID
AHRI.PrEPImplementation.Baseline.Recruitment.2022.v1
Producer(s)
Dr Maryam, Shahmanesh, ,
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Created on
Feb 15, 2023
Last modified
Feb 15, 2023
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Identification
Survey ID Number
AHRI.PrEPImplementation.Baseline.Recruitment.2022.v1
Title
Thetha Nami ngithethe nawe (Let’s Talk):Baseline Survey
Country
| Name | Country code |
|---|---|
| South Africa | ZA |
Abstract
Thetha Nami ngithethe nawe (Let's Talk): A stepped-wedge cluster randomised controlled trial of Social Mobilisation by peer navigators into community -based sexual health and HIV care (Including Pre-Exposure prophylaxis) to reduce sexually transmissible HIV amongst youth in rural KwaZulu-Natal, South Africa.
Study aim: The overarching goal is to identify scalable and sustainable ways to stem the HIV epidemic and its negative impact on young people aged 15-30 in rural KwaZulu-Natal (KZN), South Africa through effective implementation of biosocial HIV prevention.
Specific objectives for the trial:
1. Measure the impact of social mobilisation into decentralised SRHR services that provide tailored HIV prevention on the prevalence of transmissible HIV
2. Evaluate the acceptability, practicability, and reach of social mobilisation and decentralised SRHR with tailored HIV prevention to deliver differentiated biosocial HIV prevention
3. Inform the scale-up of differentiated biosocial HIV prevention and create an infrastructure to rapidly evaluate new products
Study aim: The overarching goal is to identify scalable and sustainable ways to stem the HIV epidemic and its negative impact on young people aged 15-30 in rural KwaZulu-Natal (KZN), South Africa through effective implementation of biosocial HIV prevention.
Specific objectives for the trial:
1. Measure the impact of social mobilisation into decentralised SRHR services that provide tailored HIV prevention on the prevalence of transmissible HIV
2. Evaluate the acceptability, practicability, and reach of social mobilisation and decentralised SRHR with tailored HIV prevention to deliver differentiated biosocial HIV prevention
3. Inform the scale-up of differentiated biosocial HIV prevention and create an infrastructure to rapidly evaluate new products
Kind of Data
Survey Data
Unit of Analysis
Young men and women aged 15-30 residing in one of the 40 administrative areas (clusters)
Version
Version Description
V1.0.0
Scope
Topics
| Topic | Vocabulary | URI |
|---|---|---|
| Adolescents; young adults; HIV infections/prevention & control; South Africa/epidemiology; sexual health; randomised controlled trials. | Africa Health Research Institute | www.ahri.org |
Keywords
| Keyword | Vocabulary | URI |
|---|---|---|
| HIV; viral load; contraception; sexual behaviour; PHQ9 | Africa Health Research Institute | www.ahri.org |
Coverage
Geographic Coverage
Demographic surveillance area of the Africa Health Research Institute; KwaZulu-Natal, uMkhanyakude district.
Universe
About 26,000 15-30-year-old men and women residing in 40 geographical areas (clusters) of the uMkhanyakude district in rural KwaZulu Natal are eligible to receive Let's Talk intervention, of which ~20% are at risk of HIV acquisition and would benefit from PrEP. The unit of randomisation is the administrative area supported by a pair of peer navigators: 40 administrative areas will be randomised to receive the intervention, Thetha Nami ngithethe nawe (social mobilisation by peer navigators into mobile sexual and reproductive health clinics that provide tailored HIV prevention and care) or standard of care (access HIV care and prevention through primary care clinics).
The primary outcome will be collected through three random representative population-based surveys of n=2000 15-30-year-olds, 50 per cluster, at baseline, at the end of period 1 and at the end of period 2. We use the AHRI health and demographic surveillance as a sampling frame to randomly select three separate cross-sectional samples of n=3600 (90 per cluster) 15-30-year-olds stratified by gender at baseline, midpoint (before the second step of scale up) and end-line. Based on previous studies in this setting, we anticipate that ~2800 will be contactable and eligible and that n=2000 (~50 per cluster) men and women aged 15-30, will be willing and able to provide consent to be included in the study. Participants must be able and willing to give written informed consent for trial participation, or assent and parental consent in the case of those aged 15-17.
The primary outcome will be collected through three random representative population-based surveys of n=2000 15-30-year-olds, 50 per cluster, at baseline, at the end of period 1 and at the end of period 2. We use the AHRI health and demographic surveillance as a sampling frame to randomly select three separate cross-sectional samples of n=3600 (90 per cluster) 15-30-year-olds stratified by gender at baseline, midpoint (before the second step of scale up) and end-line. Based on previous studies in this setting, we anticipate that ~2800 will be contactable and eligible and that n=2000 (~50 per cluster) men and women aged 15-30, will be willing and able to provide consent to be included in the study. Participants must be able and willing to give written informed consent for trial participation, or assent and parental consent in the case of those aged 15-17.
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 |
|---|---|---|
| Bill and Melinda Gates foundation | BMG | Funder |
Other Identifications/Acknowledgments
| Name | Affiliation | Role |
|---|---|---|
| Jaco Dreyer | Africa Health Research Institute | Data management, cleaning and analysis |
Sampling
Sampling Procedure
We randomly selected 2000 young people aged 15-30 stratified by age and sex in each cluster (administrative area). Then the selected participants were invited to participate in the survey.
Data Collection
Dates of Data Collection
| Start | End |
|---|---|
| 2022-05-26 | 2022-12-08 |
Data Processing
Data Editing
Data collected by the peer navigators and clinic staff will be captured electronically on tablets using REDCap software. Automatic checks for invalid values, internal inconsistency and implausible responses will be programmed into REDCap, and additional data validation checks will be run after data collection. Data from REDCap will be uploaded to a MySQL database server within a secure server cluster at AHRI.
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.AHRI.PrEPImplementation.Baseline.Recruitment.2022.v1
Producers
| Name | Abbreviation |
|---|---|
| Africa Health Research Institute | AHRI |