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Recruiting NCT07194902

HIV Self-testing for Partners of HIV-uninfected Postpartum Women

No phase Interventional HIV Self-testing Male Partners of HIV-negative Postpartum Women PrEP Uptake Feasibility

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: HIVST for Partners and PrEP uptake for HIV-uninfected Postpartum Women ("H4P")..
Who it may be relevant to
Registry conditions: HIV Self-testing, Male Partners of HIV-negative Postpartum Women, PrEP Uptake, Feasibility. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
South Africa
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

HIV Self-testing for Partners of HIV-uninfected Postpartum Women to Facilitate PrEP and Antiretroviral Therapy Uptake to Promote HIV Treatment and Prevention

Overview

The purpose of this study is to test the feasibility and acceptability of a combination intervention to promote HIV self-testing (HIVST) for Partners and PrEP uptake for HIV-uninfected Postpartum Women ("H4P"). H4P includes evidence-based cognitive behavioral therapy (CBT) strategies, such as communication skills training, motivational interviewing, and problem-solving. The investigators will conduct a randomized pilot trial of the H4P intervention to evaluate the feasibility, acceptability, and preliminary effectiveness of a multi-step PrEP uptake and HIV self-test kit intervention for postpartum HIV-uninfected women (N = 60 and their male partners) who report a partner of unknown serostatus, and their partners, in the province of KwaZulu-Natal, South Africa.

Interventions

  • Behavioral HIVST for Partners and PrEP uptake for HIV-uninfected Postpartum Women ("H4P").
    For female participants, the intervention includes a 30-45 minute counseling session that will cover (1) SOC PrEP information, (2) communications skills training for HIVST kit distribution, (3) Motivational interviewing strategies (e.g., PrEP/HIVST pros/cons), (4) problem-solving barriers to PrEP uptake or HIVST distribution, (5) linkage enablers (e.g., care sites, transportation, asking questions of providers). For their male partners, an informative video will cover geographically diverse HIV

Primary outcome measures

  • Feasibility of intervention [Time frame: Baseline and 3-month follow-up]
  • Acceptability [Time frame: Post-Intervention]
  • Safety concerns as a result of HIVST distribution [Time frame: Baseline and 3-month follow-up]
  • Preliminary effectiveness of H4P intervention. [Time frame: 3-month follow-up]
  • Challenges, successes, barriers, facilitators, and preferences for optimizing H4P intervention. [Time frame: 3-month follow-up]
Secondary outcome measures (11)
  • Estimate PrEP uptake among female participants [Time frame: 3-month follow-up]
  • HIV and Pregnancy characteristics [Time frame: Baseline and 3-month follow-up]
  • Physical health [Time frame: Baseline and 3-month follow-up]
  • Depression [Time frame: Baseline and 3-month follow-up]
  • Substance Use [Time frame: Baseline and 3-month follow-up]
  • Health beliefs [Time frame: Baseline]
  • Relationship characteristics and communication [Time frame: Baseline and 3-month follow-up]
  • Partner Violence [Time frame: Baseline and 3-month follow-up]
  • HIV-related stigma [Time frame: Baseline and 3-month follow-up]
  • Structural barriers [Time frame: Baseline and 3-month follow-up]
  • Demographics [Time frame: Baseline]

Eligibility criteria

Female Inclusion Criteria:

  • woman
  • Age ≥18
  • ≥30 weeks pregnant per medical record due date
  • non-reactive third trimester HIV test (verified from their antenatal care chart)
  • reporting at least one unknown-serostatus partner
  • fluent in English or isiZulu
  • willing to give researchers permission to contact them for repeated assessments
  • able to provide informed consent

Male Inclusion Criteria: partners meeting the inclusion criteria as described above, and who complete verification questions to confirm their identity and status as the partners of the enrolled female participants. Additional inclusion criteria for men include:

  • man
  • Age ≥18
  • partner of enrolled women, confirmed via couples verification tool
  • fluent in English or isiZulu
  • willing to give researchers permission to contact them
  • able to provide informed consent.

Exclusion Criteria: Individuals with significant psychiatric illness that could interfere with participation or the ability to provide informed consent will be excluded at the discretion of the study team.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Health services research

Study locations

South Africa · 1 center
  • Wits MatCH Research Unit — Durban

Publications

  • Psaros C, Beesham I, Mosery N, Aoun ZR, Bhardwaj A, Ndlovu L, Ntanzi N, Pratt MC, Chikovore J, Smit JA, Matthews LT. HIV self-testing for partners of postpartum women to facilitate HIV pre-exposure prophylaxis and antiretroviral therapy uptake: a protocol to adapt and pilot an intervention via a pilot randomised controlled trial in South Africa. BMJ Open. 2026 Jun 9;16(6):e121917. doi: 10.1136/bmj PMID 42264526

Identifiers

NCT: NCT07194902 · 2025P002271 · R34MH132446

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗