The Impact and Cost-effectiveness of Safer Conception Strategies for HIV-discordant Couples (SAFER) (NCT03049176) | Clinical Trial Compass
CompletedNot Applicable
The Impact and Cost-effectiveness of Safer Conception Strategies for HIV-discordant Couples (SAFER)
Zimbabwe46 participantsStarted 2017-03-13
Plain-language 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.
Who can participate
Age range18 Years – 35 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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