Safer Conception for Women - Understanding Use of Periconception PrEP

HIV Prevention Clinical Trial

Official title:

Safer Conception for Women: PrEP Uptake/Adherence to Reduce Periconception HIV Risk for South African Women

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03194308
• Other study ID #: 2016P001535
• Secondary ID: 1R01MH108412
• Status: Completed
• Phase: Phase 4
• Start date: November 13, 2017
• Est. completion date: July 21, 2021

Study information

• Verified date: October 2023
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Women who choose to conceive with an infected or unknown serostatus partner in HIV-endemic settings need prevention strategies to reduce periconception HIV acquisition risk. Women at high risk for acquiring HIV during pregnancy need risk reduction strategies to protect themselves and their babies. Evaluating uptake of and adherence to antiretrovirals as pre-exposure prophylaxis in this population is crucial to understanding whether and how this novel prevention strategy should be incorporated into HIV-risk reduction packages for at- risk women planning or with pregnancy.

Description:

In HIV-endemic settings, many HIV-uninfected women choose to conceive with an HIV-infected or unknown-serostatus partner. For a woman who cannot depend on a partner to test, initiate and adhere to ART, sex without condoms puts her at high risk of acquiring HIV and increases the risk of perinatal transmission to her child. Daily, oral TDF/FTC PrEP dramatically reduces a woman's risk of HIV-acquisition and is the only female-controlled option for reducing the risk of periconception HIV-acquisition. Understanding whether daily, oral PrEP is feasible for uninfected women seeking pregnancy is critical to reducing HIV incidence among women and their children.

Placebo-controlled trials identified adherence as a major challenge to long-term PrEP use. However, women are eager for prevention strategies that allow for conception, and we hypothesize that adherence to a proven prevention strategy, for a limited time with the motivation to have a healthy child, will confer drug levels required to prevent HIV transmission. This project will inform whether daily, oral PrEP is a feasible HIV-prevention strategy for South African women who intend to conceive with risky partners. Given the repercussions of acquiring HIV during conception and pregnancy, this is an important step towards providing a key prevention strategy to women and their children.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 330
• Est. completion date: July 21, 2021
• Est. primary completion date: July 21, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

Inclusion Criteria:

• Female, Aged 18-35 years

• Not pregnant, HIV-uninfected

• Likely to be fertile based on responses to reproductive history assessment

• Not on a long-acting family planning method

• Likely to have a child in the next year, either by response to modified CDC Pregnancy Risk Assessment [2-5]), or meeting the other inclusion criteria.

• With a stable (>= 6 months) partner she reports as HIV-infected or HIV-serostatus unknown, (if >1 desired pregnancy partner, we will ask her to identify the most likely pregnancy partner- based on her own assessment of sexual frequency, fertility, etc.)

• Able to participate in the informed consent process

• Fluent in English or isiZulu

Exclusion Criteria:

• Living at or planning to relocate to a location incompatible with study participation in the next year

• Active drug or alcohol use that, in the opinion of the research study team, would interfere with adherence to study requirements

• Active illness requiring systemic treatment and/or hospitalization within 30 days prior to study entry that in the opinion of the research study team, might otherwise interfere with adherence to study requirements

• Inability to adhere to the study schedule and/or study procedures

• Enrolment in studies which may conflict with their participation in this proposed study.

Related Conditions & MeSH terms

• Conception
• HIV Prevention

Intervention

Behavioral:
• PrEP for Safer Conception
Evaluation of uptake of and adherence to PrEP and safer conception strategies including: CHCT, ART for the infected partner, and uptake of contraception for those who decide not to conceive by enrolled women, during periconception and pregnancy follow up.

Locations

Country	Name	City	State
South Africa	Maternal, Adolescent, and Child Health Research Unit (MRU)	Durban	KwaZulu-Natal

Sponsors (4)

Lead Sponsor	Collaborator
Massachusetts General Hospital	National Institute of Mental Health (NIMH), National Institutes of Health (NIH), University of Witwatersrand, South Africa

Country where clinical trial is conducted

South Africa, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of uptake of and adherence to PrEP	The primary objective will be the evaluation of uptake of (collection of one month's supply) and adherence to PrEP (measured by quarterly plasma tenofovir levels) by women, during periconception and pregnancy follow up.	minimum of 12 months through pregnancy outcome (maximum 21 months)
Secondary	Safer Conception Strategies	Secondary outcomes include uptake of safer conception strategies including CHCT, ART for the infected partner, uptake of contraception for those who decide not to conceive; HIV transmission events, infant outcomes, and findings from qualitative interviews to further inform the conceptual framework for periconception PrEP uptake and adherence.	minimum of 12 months through pregnancy outcome (maximum 21 months)