Summary

Eligibility
for people ages 18 years and up (full criteria)
Dates
study started
study ends around
Principal Investigator
by Nicole Montanez

Description

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.

Official Title

ACT-PrEP Study: Aetiological STI Testing (Point-of-care), Cognitive Behavioral Counselling, and Targeted Partner Engagement to Support PrEP Enrolment and Persistence in Pregnant and Postpartum Women in South Africa

Keywords

HIV, PrEP, Acceptability, Appropriateness, Feasibility, Implementation Science, Blood Cell Count, Postpartum Period, Standard of Care, POC STI testing, CBC, and partner self-testing to improve PrEP uptake and persistence among pregnant and postpartum women.

Eligibility

You can join if…

Open to people ages 18 years and up

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

You CAN'T join if...

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

Lead Scientist at UCLA

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, Los Angeles
ID
NCT07867990
Study Type
Interventional
Participants
Expecting 120 study participants
Last Updated