Thetha Nami Ngithethe Nawe (Let's Talk): A Step-wedge cRCT of Social Mobilisation by Peer-navigators Into Community-based Sexual Health and HIV Care (Incl. PrEP) to Reduce Sexually Transmissible HIV Amongst Youth in Rural KwaZulu-Natal

Status: Recruiting
Location: See location...
Intervention Type: Combination product, Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 15
Maximum Age: 30
Healthy Volunteers: t
View:

• Resident in the cluster

• Any gender

• Aged 15-30

• If aged 18-30 and able and willing to consent to participate

• If aged 15-17, able and willing to assent and whose guardian or parent are able and willing to consent to their participation.

Locations
Other Locations
South Africa
Africa Health Research Institute
RECRUITING
Somkele
Contact Information
Primary
Maryam Shahmanesh, PhD
m.shahmanesh@ucl.ac.uk
07776185572
Time Frame
Start Date: 2022-05-26
Estimated Completion Date: 2025-05-01
Participants
Target number of participants: 6000
Treatments
Experimental: community-based differentiated biosocial HIV prevention (incl. PrEP) with SRH
The intervention is available to all 15-30 year olds residing in the intervention cluster. Area based peer navigators mobilise all young people living in their cluster. They provide sexual health promotion, condoms, HIV self-tests, pregnancy test, and conduct structured psychosocial and health needs assessment with the young people they support. Based on the needs assessment they develop a tailored plan which includes, varying degrees of peer-mentorship and psychosocial support, lay-counselling and ART/PrEP adherence support. The peer navigators refer young people to mobile SRH services. The mobile SRH services provide gender and HIV status neutral nurse-led HIV testing, Individualised risk assessments for HIV care and PrEP, contraception and wider SRH services. The nurses liaise with the peer navigators to provide ongoing support for 3-monthly follow-ups with repeat HIV testing, adherence support and PrEP/ART/contraception refills.
Active_comparator: Standard of Care
SOC is available to all young people in the delayed clusters. Care is provided in a nurse led Primary Health Clinics (PHC) to young people who attend the clinic. This includes HIV counselling and point of care testing, immediate initiation of ART if positive and PrEP if negative and eligible according to South African National PrEP guidelines. This is followed by a 3-monthly follow-up with repeat HIV testing, safety bloods, clinic-based counselling and adherence support and PrEP/ART refills. Clinic attendees are offered family planning support and syndromic management for STIs (as per South African National Department of Health Guideline).
Related Therapeutic Areas
Sponsors
Leads: Africa Health Research Institute

This content was sourced from clinicaltrials.gov