NCT05405582

Thetha Nami Ngithethe Nawe ("Let's Talk"): Step Wedge cRCT of Peer Led Community PrEP and SRH for Youth in South Africa

Status unknown NA Last updated 2 February 2024

What this trial tests

NA trial testing Community-based differentiated HIV prevention incl.PrEP with SRH in HIV-1-infection in 6,000 participants. Status unknown.

Timeline

26 May 2022

Primary endpoint
1 February 2025

1 May 2025

Quick facts

Lead sponsor	Africa Health Research Institute
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	prevention
Enrollment	6,000
Start date	26 May 2022
Primary completion	1 February 2025
Estimated completion	1 May 2025
Sites	1 location across South Africa

Drugs / interventions tested

• Community-based differentiated HIV prevention incl.PrEP with SRH
• Primary Health Clinic based HIV prevention and care

Conditions studied

• HIV-1-infection — all drugs for HIV-1-infection →
• Sexually Transmitted Diseases — all drugs for Sexually Transmitted Diseases →

Sponsor

Africa Health Research Institute

Who can join

Adults 15 to 30, any sex, with HIV-1-infection or Sexually Transmitted Diseases. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Study Hypothesis: Social mobilisation will attract and engage young people into decentralised sexual reproductive health (SRH) services where HIV prevention is tailored to need. Decentralised risk informed (differentiated) biosocial HIV prevention will reduce the overall prevalence of sexually transmissible HIV amongst young people aged 15-30.

Study aims:

1. Measure the impact of social mobilisation into decentralised SRH services that provide tailored HIV prevention on the prevalence of transmissible HIV.
2. Evaluate the acceptability, practicability, and reach of social mobilisation and decentralised SRH with tailored HIV prevention to deliver differentiated biosocial HIV prevention.

Study design: A step-wedge cluster randomised control trial comparing the effect of the Intervention (social mobilisation by peer navigators into mobile nurse-led SRH clinics) with Standard of Care (SoC) at Primary Health Care clinics, in reducing the proportion of 15-30 year olds with sexually transmissible HIV and increased uptake of risk-informed (differentiated) HIV prevention Intervention: Peer navigator social mobilisation intervention includes safe spaces, structured psychosocial and health needs assessment; Peer-mentorship with tailored health promotion, psychosocial support and lay-counselling; provision of condoms, HIV self-tests and pregnancy tests. The mobile SRH clinics provide sexually transmitted infection (STI) care, contraception, HIV testing and antiretroviral therapy (ART) if positive and Pre-Exposure Prophylaxis (PrEP) for those eligible (based on national guidelines) and negative.

SoC at Primary Health care clinics includes, contraception, HIV testing and ART if positive and PrEP for those eligible and negative.

Population: The eligible population are \~26,000 15-30-year-old residing in 40 administrative areas (clusters) of the uMkhanyakude district in rural KwaZulu Natal. The 40 clusters will undergo a stratified randomisation to early versus delayed intervention roll out.

Data collection: Research data will be collected from four sources: i) three random representative surveys of n= 2000, 15-30-year-olds; ii) programme, process, and clinical data; iii) qualitative data collected during the process evaluation iv) cost data using bottom-up ingredient-based costing and top-down costing using the budgets and expenditure reports.

Study Duration: 36 months.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Thetha Nami ngithethe nawe (Let's Talk): a stepped-wedge cluster randomised trial of social mobilisation by peer navigators into community-based sexual health and HIV care, including pre-exposure prophylaxis (PrEP), to reduce sexually transmissible HIV amongst young people in rur
   Busang J, Zuma T, Herbst C, Okesola N, et al · · 2023 · cited 9× · PMID 37582746 · DOI 10.1186/s12889-023-16262-x
2. Person-centred HIV care and prevention for youth in rural South Africa: preliminary implementation findings from Thetha Nami ngithethe nawe stepped-wedge trial of peer-navigator mobilization into mobile sexual health services.
   Busang J, Ngoma N, Zuma T, Herbst C, et al · · 2025 · cited 1× · PMID 41059644 · DOI 10.1002/jia2.70032
3. Thetha Nami ngithethe nawe (Let’s Talk): a stepped-wedge cluster randomised trial of social mobilisation by peer navigators into community-based sexual health and HIV care, including pre-exposure prophylaxis (PrEP), to reduce sexually transmissible HIV amongst young people in rur
   Busang J, Zuma T, Herbst C, Okeselo N, et al · · 2023 · DOI 10.21203/rs.3.rs-2804513/v1