Clinical trial NCT03049176: The Impact and Cost-effectiveness of Safer Conception Strategies for HIV-discordant Couples (SAFER)
Official title: The Impact and Cost-effectiveness of Safer Conception Strategies for HIV-discordant Couples
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV Infections
Keywords: HIV-discordant couple
ART
PrEP
semen washing
artificial vaginal insemination
safer conception
pregnancy
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: UZ-UCSF Collaborative Research Programme
name: National Institute of Mental Health (NIMH)
name: Gilead Sciences
First posted: 2017-02-09
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: HIV-discordant couples in Harare, Zimbabwe who are trying to get pregnant

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.

Eligibility criteria: 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

Primary outcomes:
measure: Uptake of safer conception strategies
timeFrame: 12 months
measure: Acceptability of safer conception strategies
timeFrame: 12 months
measure: Adherence to safer conception strategies
timeFrame: 12 months
Secondary outcomes:
measure: Effectiveness of safer conception strategies on HIV prevention
timeFrame: 12 months
measure: Effectiveness of safer conception strategies on achieving pregnancy
timeFrame: 12 months
measure: costs of providing safer conception services
timeFrame: 12 months
measure: cost-effectiveness of safer conception strategies
timeFrame: 12 months
Other outcomes:
Locations:
city: Harare
country: Zimbabwe
facility: UZCHS-UCSF CTRC Zengeza Clinical Research Site
Study officials:
affiliation: University of California, San Francisco
name: Joelle M Brown, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: UZ-UCSF Collaborative Research Programme
name: Felix Mhlanga, MBChB, MMed
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hughes CS, Brown J, Murombedzi C, Chirenda T, Chareka G, Mhlanga F, Mateveke B, Gitome S, Makurumure T, Matubu A, Mgodi N, Chirenje Z, Kahn JG. Estimated costs for the delivery of safer conception strategies for HIV-discordant couples in Zimbabwe: a cost analysis. BMC Health Serv Res. 2020 Oct 12;20(1):940. doi: 10.1186/s12913-020-05784-4.