The ACT-PrEP Study

Brief summary (registry, in English)

AIM: To evaluate the integration of point-of-care etiological STI testing, cognitive behavioral counselling (CBC), and sexual partner engagement strategies to improve STI management, PrEP uptake and 3-month PrEP persistence among pregnant and postpartum women PRIMARY OBJECTIVE: To evaluate the effect of the intervention on 3-month PrEP persistence among pregnant and postpartum women (PPW) SECONDARY OBJECTIVE: Determine the proportion of PPW initiating PrEP Determine the prevalence of STIs among pregnant and postpartum women Determine the feasibility and acceptability of aetiological STI testing within the antenatal and postnatal clinical workflows by HCPs Determine the acceptability and uptake of HIV/STI services by partners of pregnant and postpartum women STUDY DESIGN AND POPULATION: One-site, two-arm, individually randomized controlled type-1 hybrid implementation pilot This pilot study will follow a type-1 hybrid implementation-effectiveness design to be implemented at a public sector primary healthcare centre with a high HIV/STI burden (Gugulethu Community Health Centre). Enrollment: 120 pregnant women attending a routine care visit. Follow-up visits may fall in the post-partum period depending on age of gestation upon enrollment. Inclusion criteria include: 1) age ≥18 years; 2) HIV-negative, 3) minimum gestational age of 18 weeks for pregnant women, and 4) eligible for PrEP as per South African guidelines. Exclusion criteria include: 1) inability to provide informed consent, 2) medical contraindications to PrEP. Sexual partners of PPW will be engaged through the distribution of HIV/syphilis self-test kits, and 10 healthcare providers will participate in cognitive behavioral counselling (CBC) training and competency assessments.

What you commit to

• Study type: Interventional
• Planned participants: 120
• From 2 Oct 2026 to the primary completion date, 1 Dec 2026
• No sites listed in no country
• Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Who the study is looking for

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov