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

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