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

NCT05405582 | Recruiting DMC

• 1 other identifier: INV-033650
• Study Type: interventional
• Target: 6,000
• Locations: 1 country
• Sites: 1

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

Conditions

HIV-1-infection; Sexually Transmitted Diseases

Outcome Measures

Primary Outcomes (3)

• Prevalence of sexually transmitted HIV

  The proportion of those aged 15-30 who are HIV positive and have a detectable HIV viral load defined as having an HIV viral load of \>= 400 copies per ml, in the intervention arm compared to control

  36 months

• The uptake of risk informed biomedical HIV prevention

  The proportion of participants who are aware of HIV status; on treatment if positive; and have undergone risk assessment by peer navigators or SRH clinic if HIV negative (and taken up PrEP if HIV negative and eligible) in the intervention arm compared to control.

  36 months

• The cost of transmissible HIV averted.

  The cost per transmissible HIV case averted and the cost per case linked to risk differentiated biosocial HIV prevention.

  36 months

Secondary Outcomes (10)

• Uptake of contraception

  36 months

• Uptake of voluntary male medical circumcision

  36 months

• Prevalence of Sexually Transmitted Infections

  36 months

• Teenage pregnancy and fatherhood

  36 months

• Proportion of men and women aged 15-30 at risk of acquiring HIV or transmitting HIV

  36 months

Other Outcomes (2)

• Common mental disorder

  36 months

• Retention in PrEP

  36 months

Study Arms (2)

community-based differentiated biosocial HIV prevention (incl. PrEP) with SRH

EXPERIMENTAL

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.

Combination Product: Community-based differentiated HIV prevention incl.PrEP with SRH

Standard of Care

ACTIVE COMPARATOR

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).

Other: Primary Health Clinic based HIV prevention and care

Interventions

Community-based differentiated HIV prevention incl.PrEP with SRH COMBINATION_PRODUCT

Community-based model of care, that consists of social mobilisation by area-based peer-navigator into decentralised sexual reproductive health (SRH) and HIV care (incl. PrEP).

community-based differentiated biosocial HIV prevention (incl. PrEP) with SRH

Primary Health Clinic based HIV prevention and care OTHER

Primary Health Clinic (PHC) based initiation and follow-up with HIV testing and standard HIV prevention and treatment package. Family planning support and syndromic management for STIs as per South African National Department of Health Guideline.

Standard of Care

Eligibility Criteria

• Age: 15 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• Unable or unwilling to provide consent
• Aged 14 or less
• aged 31 or more

Sponsors & Collaborators

• Africa Health Research Institute: lead

Study Sites (1)

Africa Health Research Institute

Somkele, KwaZulu-Natal, South Africa

RECRUITING

Related Publications (2)

• Busang J, Ngoma N, Zuma T, Herbst C, Okesola N, Chimbindi N, Dreyer J, Smit T, Bird K, Mtolo L, Behuhuma O, Hanekom W, Herbst K, Lebina L, Seeley J, Copas A, Baisley K, Shahmanesh M. 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. J Int AIDS Soc. 2025 Sep;28 Suppl 5(Suppl 5):e70032. doi: 10.1002/jia2.70032.

  PMID: 41059644 DERIVED

• Busang J, Zuma T, Herbst C, Okesola N, Chimbindi N, Dreyer J, Mtshali N, Smit T, Ngubane S, Hlongwane S, Gumede D, Jalazi A, Mdluli S, Bird K, Msane S, Danisa P, Hanekom W, Lebina L, Behuhuma N, Hendrickson C, Miot J, Seeley J, Harling G, Jarolimova J, Sherr L, Copas A, Baisley K, Shahmanesh M. 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 rural KwaZulu-Natal, South Africa. BMC Public Health. 2023 Aug 15;23(1):1553. doi: 10.1186/s12889-023-16262-x.

  PMID: 37582746 DERIVED

MeSH Terms

Conditions

Sexually Transmitted Diseases

Condition Hierarchy (Ancestors)

Communicable Diseases; Infections; Genital Diseases; Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Maryam Shahmanesh, PhD

CONTACT

07776185572; m.shahmanesh@ucl.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Restricted randomisation was used to randomly allocate administrative areas in equal measure (to early and delayed roll-out of the intervention steps (20:20). Restricted randomisation was used to ensure that the intervention steps are reasonably balanced with respect to key characteristics (obtained from the HDSS) specifically, adolescent and young adult population size and density, new versus old areas, and geographic location along the N2 road. Interventions were assigned during a public ceremony to ensure transparency and fairness in the randomisation and engagement of the community. Randomisation and allocation were kept separate throughout. The statistician and investigators did not participate in the public randomisation and will remain blinded until the analyses of primary and randomised secondary outcomes have been finalised. Investigators remain blinded to allocation throughout. The participants and intervention delivery teams are not blinded.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: step wedge cluster randomised controlled trial

Study Record Dates

• First Submitted: May 27, 2022
• First Posted: June 6, 2022
• Study Start: May 26, 2022
• Primary Completion: February 1, 2025
• Study Completion: May 1, 2025
• Last Updated: February 2, 2024

Record last verified: 2024-02

Locations

ZA (1)