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

University of California, San Francisco46 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

HIV Infections

Interventions

PrEP (Truvada)DRUG

oral, daily Truvada for HIV-negative participants

AntiretroviralsDRUG

oral daily antiretrovirals and frequent viral load monitoring for HIV-positive participant

Semen washingPROCEDURE

collection of semen from an HIV-positive man, processing semen to remove HIV, followed by intrauterine insemination

Eligibility

Sex: ALLMin age: 18 YearsMax age: 35 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

UZCHS-UCSF CTRC Zengeza Clinical Research Site

Harare, Zimbabwe

Outcomes

Primary Outcomes

Uptake of safer conception strategies

proportion of couples choosing the strategy

Time frame: 12 months

Acceptability of safer conception strategies

proportion of couples remaining on strategy; reports of satisfaction

Time frame: 12 months

Adherence to safer conception strategies

proportion of couples with high adherence to strategy

Time frame: 12 months

Secondary Outcomes

Effectiveness of safer conception strategies on HIV prevention

incidence of HIV

Time frame: 12 months

Effectiveness of safer conception strategies on achieving pregnancy

incidence of pregnancy

Time frame: 12 months

costs of providing safer conception services

costs

Time frame: 12 months

cost-effectiveness of safer conception strategies

model the cost effectiveness of various combinations of safer conception strategies

Time frame: 12 months

Data from ClinicalTrials.gov

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