Thetha Nami ngithethe nawe (Let’s Talk):Midline Survey
South Africa, 2023 - 2024
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AHRI.PrEPImplementation.MS.Midline.Survey.2024.v2
Thetha Nami ngithethe nawe (Let’s Talk):Midline Survey
| Name | Country code |
|---|---|
| South Africa | ZA |
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:
- Measure the impact of social mobilisation into decentralised SRHR services that provide tailored HIV prevention on the prevalence of transmissible HIV
- Evaluate the acceptability, practicability, and reach of social mobilisation and decentralised SRHR with tailored HIV prevention to deliver differentiated biosocial HIV prevention
- Inform the scale-up of differentiated biosocial HIV prevention and create an infrastructure to rapidly evaluate new products
Survey Data for Midline interview
Young men and women aged 15-30 residing in one of the 40 administrative areas (clusters)
Version
V2.0.0
Scope
| 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 |
Coverage
Demographic surveillance area of the Africa Health Research Institute; KwaZulu-Natal, uMkhanyakude district.
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).
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
| Name | Affiliation |
|---|---|
| Prof. Maryam, Shahmanesh | Africa Health Research Institute (AHRI) |
| Name |
|---|
| Africa Health Research Institute |
| Name | Abbreviation | Role |
|---|---|---|
| Bill and Melinda Gates foundation | BMG | Funder |
| Name | Affiliation | Role |
|---|---|---|
| Jaco Dreyer | Africa Health Research Institute | Data management, cleaning and analysis |
| Sweetness Dube | Africa Health Research Institute | Data documentation |
Sampling
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,
· n=3200 15-30-year-olds, 80 per cluster, at the end of period 1 (midline) and
· n=3200 15-30-year-olds, 80 per cluster, at the end of period 2 (end-line).
We use the AHRI health and demographic surveillance system (HDSS) 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. 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.
· n=6000 (150 per cluster) 15-30-year-olds stratified by gender at midline (before the second step of scale up) and end-line. Based on previous studies in this setting, we anticipate that 4300 will be contactable and eligible and that n=3200 (~80 per cluster) men and women aged 15-30, will be willing and able to provide consent to be included in the study
Data collection
| Start | End |
|---|---|
| 2023-08-15 | 2024-05-23 |
Data processing
The data collected and captured on REDCap were uploaded to a MySQL database server within a secure server cluster at AHRI.
Data Access
Access to the data requires accurate completion of the online data access application form accessible on the AHRI Data repository(https://data.ahri.org/). Data users are required to abide by the data use conditions stipulated on the application for access to the data. Failure to do so may result in their data access privileges being revoked by the Data Custodian. In order to recognise the effort and intellectual contributions of AHRI investigators in producing and curating the data, users of AHRI data must acknowledge the source of the data and abide by the terms and conditions under which the data is accessed and must cite the dataset in publication using the citation provided as part of this documentation. All analytical datasets published on the AHRI Data Repository are assigned digital object identifier (DOIs) and the DOIs can be found on the Data Repository under Study Description tab - Access policy. AHRI data users are required to always cite the dataset using the relevant DOI.
Metadata production
DDI.AHRI.PrEPImplementation.MS.Midline.Survey.2024.v2
| Name | Abbreviation |
|---|---|
| Africa Health Research Institute | AHRI |