HIV/AIDS
Conditions
Interventions
Truvada
Sponsors
National Agency for the Control of AIDS
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: For heterosexual couples: 1). Sexually active (defined as having had vaginal intercourse at least 6 times in the previous three months) 2). Willing to enter the study as a couple and intending to remain as a couple for the next 12 months 3). Has not been on PrEP medication prior to enrollment in study For HIV-1 uninfected members of the couple (partner participants): 1). Able and willing to provide written informed consent 2). HIV-1 uninfected based on negative HIV-1 rapid tests, both at study screening and at the enrolment visit 3).Adequate renal function, defined by normal creatinine levels and estimated creatinine clearance ¿60 mL/min 4). Not currently pregnant or breastfeeding 5).Not currently enrolled in an HIV-1 prevention clinical trial 6). Not currently using PrEP 7). Enrolment of individuals with active and serious infections or active clinically significant medical problems will be at the discretion of the site investigator For HIV-1 infected members of the couple (index participants): 1) Able and willing to provide written informed consent 2). HIV-1 infected based on positive rapid HIV-1 tests, according to national algorithm 3). No history of WHO stage III or IV conditions 4). Not currently using ART 5). Currently using ART but viral load still higher than 5,000 copies/ml 6). Not currently enrolled in an HIV-1 treatment study. 7). Current pregnancy or breastfeeding do not disqualify a candidate who is infected.
Exclusion criteria
Exclusion criteria: 1. Currently on ART and virally suppressed
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.data and assessments about the factors that support or create barriers to clients' use of PrEP and partner's use of TasP;2.data and assessments about serodiscordant couples¿ attitudes towards ART and PrEP as for preventing HIV-1 transmission;3.data on PrEP adherence; this will be in the form of clinic-based pill counts at follow-up visits and MEMS cap data on how frequently the pill bottle was opened.;4.reduction in rate of use of condom per couple on PrEP; and rate of increase in STI diagnosed per couple on PrEP. This data will be generated from the clinical data and the behaviour surveillance data;5.an estimate of the prevalence of ART resistance that developed in patients who seroconverted while using PrEP.;6.an estimate of cost per life year gained and cost per infection averted for female sex workers and men who have sex with men | — |
Countries
Nigeria
Contacts
Public ContactJames Anenih
Study Administrator
Outcome results
None listed