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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

46 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-03-13

Study Completion Date

2019-07-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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HIV Infections

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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HIV+male/HIV-female

discordant couple given the choice of using at least one of the following: Antiretrovirals, PrEP (Truvada), or semen washing

PrEP (Truvada)

Intervention Type DRUG

oral, daily Truvada for HIV-negative participants

Antiretrovirals

Intervention Type DRUG

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

Semen washing

Intervention Type PROCEDURE

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

HIV+female/HIV-male

discordant couple given the choice of using at least one of the following: Antiretrovirals, PrEP (Truvada), or artificial vaginal insemination

PrEP (Truvada)

Intervention Type DRUG

oral, daily Truvada for HIV-negative participants

Antiretrovirals

Intervention Type DRUG

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

Artificial vaginal insemination

Intervention Type PROCEDURE

collection of semen from an HIV-negative man, followed by intravaginal insemination

Interventions

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PrEP (Truvada)

oral, daily Truvada for HIV-negative participants

Intervention Type DRUG

Antiretrovirals

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

Intervention Type DRUG

Semen washing

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

Intervention Type PROCEDURE

Artificial vaginal insemination

collection of semen from an HIV-negative man, followed by intravaginal insemination

Intervention Type PROCEDURE

Other Intervention Names

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emtricitabine/tenofovir disoproxil fumarate ART

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes