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

Completed

• Conditions: HIV Infections
• Interventions: Drug: PrEP (Truvada); Drug: Antiretrovirals; Procedure: Artificial vaginal insemination; Procedure: Semen washing

• Registration Number: NCT03049176
• Lead Sponsor: University of California, San Francisco

Brief Summary

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2017-02-07
• Study First Submitted QC: 2017-02-07
• Study First Posted: 2017-02-09
• Study Start: 2017-03-13
• Primary Completion: 2019-06-03
• Study Completion: 2019-07-31
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-27
• Last Update Posted: 2019-09-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 46

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
HIV+female/HIV-male	Antiretrovirals	discordant couple given the choice of using at least one of the following: Antiretrovirals, PrEP (Truvada), or artificial vaginal insemination
HIV+male/HIV-female	PrEP (Truvada)	discordant couple given the choice of using at least one of the following: Antiretrovirals, PrEP (Truvada), or semen washing
HIV+female/HIV-male	Artificial vaginal insemination	discordant couple given the choice of using at least one of the following: Antiretrovirals, PrEP (Truvada), or artificial vaginal insemination
HIV+female/HIV-male	PrEP (Truvada)	discordant couple given the choice of using at least one of the following: Antiretrovirals, PrEP (Truvada), or artificial vaginal insemination
HIV+male/HIV-female	Semen washing	discordant couple given the choice of using at least one of the following: Antiretrovirals, PrEP (Truvada), or semen washing
HIV+male/HIV-female	Antiretrovirals	discordant couple given the choice of using at least one of the following: Antiretrovirals, PrEP (Truvada), or semen washing

Primary Outcome Measures

Name	Time	Method
Uptake of safer conception strategies	12 months	proportion of couples choosing the strategy
Adherence to safer conception strategies	12 months	proportion of couples with high adherence to strategy
Acceptability of safer conception strategies	12 months	proportion of couples remaining on strategy; reports of satisfaction

Secondary Outcome Measures

Name	Time	Method
Effectiveness of safer conception strategies on achieving pregnancy	12 months	incidence of pregnancy
cost-effectiveness of safer conception strategies	12 months	model the cost effectiveness of various combinations of safer conception strategies
costs of providing safer conception services	12 months	costs
Effectiveness of safer conception strategies on HIV prevention	12 months	incidence of HIV

Trial Locations

Locations (1)

UZCHS-UCSF CTRC Zengeza Clinical Research Site; 🇿🇼 Harare, Zimbabwe