The ACT-PrEP Study

NCT07867990 | Not Yet Recruiting

• 1 other identifier: IRB-26-1397
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

HIV; PrEP; Acceptability; Appropriateness; Feasibility; Implementation Science

Outcome Measures

Primary Outcomes (2)

• 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.

  1 year

• 3-month PrEP persistence

  PrEP initiation

  1 year

Study Arms (2)

Intervention Arm

ACTIVE COMPARATOR

Behavioral: POC STI testing, CBC, and partner self-testing to improve PrEP uptake and persistence among pregnant and postpartum women.

Control Arm

ACTIVE COMPARATOR

Standard of Care

Other: Standard of Care

Interventions

POC STI testing, CBC, and partner self-testing to improve PrEP uptake and persistence among pregnant and postpartum women. BEHAVIORAL

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

Intervention Arm

Standard of Care OTHER

Standard of Care

Control Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age ≥18 years;
• HIV-negative,
• minimum gestational age of 18 weeks for pregnant women, and
• eligible for PrEP as per South African guidelines.

You may not qualify if:

• inability to provide informed consent,
• medical contraindications to PrEP.

Sponsors & Collaborators

• University of California, Los Angeles: lead
• University of Cape Town: collaborator

MeSH Terms

Interventions

Blood Cell Count; Postpartum Period; Standard of Care

Intervention Hierarchy (Ancestors)

Cell Count; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Hematologic Tests; Investigative Techniques; Cell Physiological Phenomena; Blood Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena; Reproductive Physiological Phenomena; Reproductive and Urinary Physiological Phenomena; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Central Study Contacts

Nicole A Montañez, MSW

CONTACT

3108255047; nmontanez@ucla.edu

Dvora Joseph Davey, PhD

CONTACT

3107942555; dvoradavey@g.ucla.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: October 1, 2026
• First Posted: October 9, 2026
• Study Start: October 2, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): June 30, 2027
• Last Updated: October 9, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share