An interventional study of POC STI testing, CBC, and partner self-testing to improve PrEP uptake and persistence among pregnant and postpartum women. and Standard of Care in HIV, PrEP and Acceptability, sponsored by University of California, Los Angeles. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-09.
Sponsored by University of California, Los Angeles · Not applicable, Interventional, and Supportive care
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.
University of California, Los Angeles is the lead sponsor of 1,167 studies on the registry; 192 are open to participants now.
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Exclusion Criteria:
Behavioral: POC STI testing, CBC, and partner self-testing to improve PrEP uptake and persistence among pregnant and postpartum women.
Standard of Care
Other: Standard of Care
2\. Study Aim and Objectives 2.1. Overall Aim To evaluate the feasibility, acceptability, and preliminary effectiveness of a multi-component intervention integrating POC STI testing, CBC, and partner self-testing to improve PrEP uptake and persistence among pregnant and postpartum women. 2.2. Primary Objective To evaluate the effect of the multi-component intervention on 3-month PrEP persistence among pregnant and postpartum women. PrEP persistence will be defined as current PrEP use at the 3-month follow-up visit (measured from enrolment), with participants who do not initiate or who discontinue PrEP classified as not persistent. 2.3. Secondary Objectives * To determine the prevalence of STIs among pregnant and postpartum women * To determine the feasibility and acceptability of aetiological STI testing within the antenatal and postnatal clinical workflows by HCPs ● To determine the acceptability and uptake of HIV/STI services by partners of pregnant and postpartum women
Standard of Care
Implementation outcomes will include feasibility, acceptability, and appropriateness of the intervention
Feasibility, acceptability, and appropriateness data tool, this is one tool that assesses the intervention using a Likert scale: 1) completely disagree, 2) disagree, 3) neutral, 4) Agree, 5) completely agree.
Time frame: 1 year
3-month PrEP persistence
PrEP initiation
Time frame: 1 year
No study locations are listed for this record.
Plan to share: No — No sharing of IPD is planned for this Pilot Study.
No publications or documents are linked to this record.
Start is estimated for Oct 2026; primary completion for Dec 2026, 1 month later.
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From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in May 2026. You cannot join it, but the record below documents what was studied.
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