Safer Conception for Women - Understanding Use of Periconception PrEP

NCT03194308 | Completed Phase 4 DMC

• 2 other identifiers: 2016P0015351R01MH108412
• Study Type: interventional
• Target: 330
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

HIV Prevention; Conception

Keywords

HIV risk reduction; Safer Conception; Pre-exposure prophylaxis; South Africa; Women; Reproductive Health

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Safer Conception Strategies

  minimum of 12 months through pregnancy outcome (maximum 21 months)

Study Arms (1)

HIV-uninfected women

OTHER

A sample of 350 HIV-uninfected women who are not currently pregnant, in a stable relationship (≥6 months) with a self-reported infected or unknown serostatus partner and personal or partner plans for pregnancy in the next 12 months. Women will be offered safer conception counseling based on South African guidelines plus daily, oral tenofovir/emtricitabine (TDF/FTC) as pre-exposure prophylaxis (PrEP) during periconception and pregnancy.

Behavioral: PrEP for Safer Conception

Interventions

PrEP for Safer Conception BEHAVIORAL

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.

HIV-uninfected women

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• National Institutes of Health (NIH): collaborator
• University of Witwatersrand, South Africa: collaborator
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Maternal, Adolescent, and Child Health Research Unit (MRU)

Durban, KwaZulu-Natal, 4001, South Africa

Location

Related Publications (3)

• Kwach B, Odoyo JB, Lauff AR, Omollo V, Rono B, Ogello V, Mann V, Kwena Z, Thomas K, Sharma M, Morton JF, Ngure K, Bukusi E, Mugwanya KK, PrEP Care Team OS. Evaluating the effectiveness of a One-Stop PrEP Care model to enhance HIV prevention: a protocol for a cluster-randomised trial in Kisumu County, Kenya. BMJ Open. 2025 Sep 8;15(9):e097792. doi: 10.1136/bmjopen-2024-097792.

  PMID: 40921636 DERIVED

• Matthews LT, Jaggernath M, Kriel Y, Smith PM, Haberer JE, Baeten JM, Hendrix CW, Ware NC, Moodley P, Pillay M, Bennett K, Bassler J, Psaros C, Hurwitz KE, Bangsberg DR, Smit JA. Oral preexposure prophylaxis uptake, adherence, and persistence during periconception periods among women in South Africa. AIDS. 2024 Jul 15;38(9):1342-1354. doi: 10.1097/QAD.0000000000003925. Epub 2024 May 27.

  PMID: 38752557 DERIVED

• Matthews LT, Jaggernath M, Kriel Y, Smith PM, O'Neil K, Haberer JE, Hendrix C, Baeten JM, Ware NC, Wirth K, Psaros C, Bangsberg DR, Smit JA. Protocol for a longitudinal study to evaluate the use of tenofovir-based PrEP for safer conception and pregnancy among women in South Africa. BMJ Open. 2019 Jul 26;9(7):e027227. doi: 10.1136/bmjopen-2018-027227.

  PMID: 31350241 DERIVED

Study Officials

• Lynn T Matthews, MD, MPH

  Mass General Hosptial

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: All participants are assigned to the Safer Conception study intervention.

Study Record Dates

• First Submitted: June 19, 2017
• First Posted: June 21, 2017
• Study Start: November 13, 2017
• Primary Completion: July 21, 2021
• Study Completion: July 21, 2021
• Last Updated: October 23, 2023

Record last verified: 2023-10

Locations

ZA (1)