About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
age ≥18 years;
HIV-negative,
minimum gestational age of 18 weeks for pregnant women, and
eligible for PrEP as per South African guidelines.
Disqualifiers
inability to provide informed consent,
medical contraindications to PrEP.
Trial design
Parallel
Treatments tested in this trial
POC STI testing, CBC, and partner self-testing to improve PrEP uptake and persistence among pregnant and postpartum women.
Behavioral2\. 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
Other interventionStandard of Care
Treatment groups
Trial outcomes
Primary outcomes
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.
3-month PrEP persistence
PrEP initiation
Locations
Sponsors and contacts
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University of California, Los Angeles
Lead sponsor
University of Cape Town
Collaborator
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