AHRI.PrEPImplementation.Baseline.Recruitment.2022.v1
Thetha Nami ngithethe nawe (Let’s Talk):Baseline Survey
Name | Country code |
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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:
Survey Data
Young men and women aged 15-30 residing in one of the 40 administrative areas (clusters)
V1.0.0
Topic | Vocabulary | URI |
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Adolescents; young adults; HIV infections/prevention & control; South Africa/epidemiology; sexual health; randomised controlled trials. | Africa Health Research Institute | www.ahri.org |
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).
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.
Name | Affiliation |
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Dr Maryam, Shahmanesh | Africa Health Research Institute |
Name |
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Africa Health Research Institute |
Name | Role |
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Bill and Melinda Gates foundation | Funder |
Name | Affiliation | Role |
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Jaco Dreyer | Africa Health Research Institute | Data management, cleaning and analysis |
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.
Start | End |
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2022-05-26 | 2022-12-08 |
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.
The representative of the Receiving Organization agrees to comply with the following conditions:
DDI.AHRI.AHRI.PrEPImplementation.Baseline.Recruitment.2022.v1
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Africa Health Research Institute |