The Impact and Cost-effectiveness of Safer Conception Strategies for HIV-discordant Couples (SAFER)

University of California San Francisco (UCSF)

Status

Completed

Conditions

HIV Infections

Treatments

Procedure: Artificial vaginal insemination

Drug: PrEP (Truvada)

Drug: Antiretrovirals

Procedure: Semen washing

Study type

Observational

Funder types

Other

Industry

NIH

Identifiers

NCT03049176

K01MH100994 (U.S. NIH Grant/Contract)

A126763

Details and patient eligibility

About

This is a prospective, non-randomized, open-label study to look at the uptake, adherence to, and impact of pre-exposure prophylaxis (PrEP), antiretroviral therapy (ART), semen washing, and vaginal insemination to prevent HIV among HIV-discordant couples attempting conception in Zimbabwe.

Full description

The reproductive needs of HIV-discordant couples who desire pregnancy represent an urgent public health problem that has been neglected in HIV prevention research. In Zimbabwe , and across sub-Saharan Africa, the vast majority of HIV-infected individuals are adults of reproductive age. Pregnancy and the desire for children are common among HIV-infected individuals, and HIV-discordant couples face a difficult choice between attempting pregnancy and risking HIV transmission to their partners. Recent surveys have found that 30-50% of HIV-infected individuals in sub-Saharan Africa are involved in stable, HIV-discordant relationships, and HIV transmission within married, cohabitating HIV-discordant couples accounts for 44-60% of new HIV infections in some regions of sub-Saharan Africa. While knowledge of HIV discordance can lead to increased condom use, many discordant couples have unprotected intercourse often motivated by the desire to conceive. Currently, HIV discordant couples who attempt to conceive place themselves at considerable risk of transmission. This research study aims to help promote couples' rights to conceive while at the same time decreasing the risk of HIV transmission.

Enrollment

46 patients

Sex

All

Ages

18 to 35 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

For all couples:

Couple expresses a desire to conceive
Sexually active (defined as having vaginal sex with one another at least 6 times in the past 3 months
Willing to enter the study as a couple and intending to remain as a couple and have a sexual relationship for the next 12 months
Willing to use at least one safer conception strategy
For men, age ≥18 years. For women, age 18 - 35 years;
Able and willing to provide written informed consent

For HIV-uninfected members of the couple

HIV-negative based on parallel negative HIV rapid tests, both at study screening and enrollment visit
Adequate renal function, defined by normal creatinine levels and estimated creatinine clearance ≥60 mL/min

For HIV-infected members of the couple

HIV-positive based on parallel positive HIV rapid tests, based on national algorithm
No current AIDS-defining illness

Exclusion criteria

Amenorrheic
Currently pregnant
Active and serious infections, including active tuberculosis infection; active clinically significant medical problems including cardiac disease, pulmonary disease, and previously diagnosed malignancy expected to require further treatment.
History of infertility defined as a year or more of regular unprotected intercourse with current partner without pregnancy, or otherwise medically diagnosed infertility
Currently on any concomitant medication that requires the participant to avoid use of PrEP