Clinical trial NCT03194308: Safer Conception for Women - Understanding Use of Periconception PrEP
Official title: Safer Conception for Women: PrEP Uptake/Adherence to Reduce Periconception HIV Risk for South African Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: HIV Prevention
Conception
Keywords: HIV risk reduction
Safer Conception
Pre-exposure prophylaxis
South Africa
Women
Reproductive Health
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: University of Witwatersrand, South Africa
name: National Institute of Mental Health (NIMH)
First posted: 2017-06-21
Enrollment: 330
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: All participants are assigned to the Safer Conception study intervention.
Primary purpose: PREVENTION

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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Evaluation of uptake of and adherence to PrEP
timeFrame: minimum of 12 months through pregnancy outcome (maximum 21 months)
Secondary outcomes:
measure: Safer Conception Strategies
timeFrame: minimum of 12 months through pregnancy outcome (maximum 21 months)
Other outcomes:
Locations:
city: Durban
country: South Africa
facility: Maternal, Adolescent, and Child Health Research Unit (MRU)
state: KwaZulu-Natal
Study officials:
affiliation: Mass General Hosptial
name: Lynn T Matthews, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.