Safer Conception for Women - Understanding Use of Periconception PrEP

Status Completed

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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03194308
Study type	Interventional
Source	Massachusetts General Hospital
Contact
Status	Completed
Phase	Phase 4
Start date	November 13, 2017
Completion date	July 21, 2021

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT03411577` - Development and Testing of a Jamaican Mother-daughter HIV Risk-reduction Program	N/A
Active, not recruiting	`NCT03112369` - Preventing HIV Among Native Americans Through the Treatment PTSD & Substance Use	N/A
Not yet recruiting	`NCT03642314` - HIV Self-testing in Implementation PrEP Study	N/A
Completed	`NCT01810315` - Influence of Reproductive Cycle and Menopause on HIV-1 Infection and TFV Gel Activity	Phase 1
Completed	`NCT00984971` - Rectal Microbicide Safety and Acceptability Trial of Topically Applied Tenofovir Compared With Oral Tablet	Phase 1
Completed	`NCT00142935` - Effectiveness of Opiate Replacement Therapy Administered Prior to Release From a Correctional Facility - 1	N/A
Active, not recruiting	`NCT03255915` - PrEP-Pod-IVR (TDF-FTC/Placebo IVR 28 Day Crossover Study)	Early Phase 1
Completed	`NCT05037513` - Integrated PrEP Interventions for People Who Inject Drugs in Rural Kentucky	N/A
Recruiting	`NCT05087680` - An Acceptance Based PrEP Intervention to Engage Young Black MSM in the South	N/A
Recruiting	`NCT05804461` - Optimizing Pre-Exposure Prophylaxis (PrEP) Among Latino Men Who Have Sex With Men (MSM) in Puerto Rico	N/A
Completed	`NCT03148171` - Project WERK (Wellness Encouragement Respect Kinship)	N/A
Completed	`NCT04791007` - OB-002H Gel Administered Vaginally and Rectally in HIV-1 Seronegative Adults	Early Phase 1
Recruiting	`NCT05412433` - Clinic-based HIV Identification and Prevention Project Using Electronic Resources	N/A
Active, not recruiting	`NCT03977181` - The Community PrEP Study to Assess the Acceptance of PrEP Delivered Through CBCT Platforms	N/A
Recruiting	`NCT05165745` - Stick2PrEP Cisgender Women and Trans Individuals	N/A
Completed	`NCT03719053` - Single Dose Truvada Study	Phase 1
Recruiting	`NCT03856580` - Long-acting Biomedical HIV Prevention in Transgender Women	N/A
Completed	`NCT02750540` - Optimization of a Tenofovir Enema for HIV Prevention	Phase 1
Completed	`NCT01386294` - Safety and Effectiveness of Tenofovir Gel in the Prevention of Human Immunodeficiency Virus (HIV-1) Infection in Women and the Effects of Tenofovir Gel on the Incidence of Herpes Simplex Virus (HSV-2) Infection	Phase 3
Completed	`NCT00993811` - The Shang Ring: A Novel Male Circumcision Device for HIV Prevention	Phase 1