HIV assays used, by study site.

<p>HIV assays used, by study site.</p

HIV test results.

<p>HIV test results.</p

Univariable and multivariable regressions of factors correlating with <80% electronic monitoring adherence.

<p>Less than 80% adherence was seen among 282 participants in 14.4% of study quarters. MEMS data were available for 4,357 of 4,463 (97.2%) study quarters.</p>a<p><i>n</i> (row %) or mean (SD).</p>*<p>Bold indicates <i>p</i><0.05.</p

Distribution of adherence by unannounced pill count and electronic monitoring.

<p>Distribution of adherence by unannounced pill count and electronic monitoring.</p

Enrollment characteristics of study participants.

<p>Complete data were available on all variables (<i>n</i> = 1,147) except for questions regarding unprotected sex in the prior month (missing in 3%), polygamy (<1%), and viral load (1%).</p>a<p>From the three sites from which the adherence substudy recruited.</p><p>n/a, not applicable.</p

Distribution of components of the couples’ HIV-1 empiric risk score.

<p>Distribution of components of the couples’ HIV-1 empiric risk score.</p

Screening, enrollment, and follow-up.

<p>Reasons for ineligibility are not mutually exclusive. A total of 1,013 higher-risk HIV-1-serodiscordant couples were enrolled. Of the initially HIV-1-seronegative partners, 12 subsequently seroconverted to HIV-1 but were found to have HIV-1 RNA in archived plasma from the time of enrollment, indicating acute seronegative HIV-1 infection.</p

Characteristics of the study subjects at enrollment (N = 1013 couples).

<p>Characteristics of the study subjects at enrollment (N = 1013 couples).</p

Couple ART and PrEP use over time.

<p>This graph illustrates the overall distribution of ART use by HIV-1-infected partners and PrEP use by HIV-1-uninfected partners within the study partnerships, over follow-up. The proportion of couples using only PrEP for HIV-1 prevention declined over time, as HIV-1-infected participants initiated ART, as defined by the PrEP as a bridge to ART approach of the project. Through month 6, there was the greatest overlap between ART and PrEP; thereafter, couples with HIV-1 infected partners that initiated ART at or soon after enrollment begin to discontinue PrEP. The primary reason for couples using neither ART nor PrEP was missed visits, which were considered as not exposed to PrEP (since PrEP was distributed only at the study sites during the study period) nor to ART (which was assumed to have not been initiated until first reported).</p

HIV-1 incidence, expected versus observed.

<p>Expected HIV-1 incidence was estimated from a counterfactual model, bootstrapping data from a comparable at-risk population of HIV-1-serodiscordant couples. The graphic presents results for the entire study population. The table details the overall population estimates as well as analyses stratified by gender of the HIV-1-uninfected partner and baseline plasma HIV-1 RNA concentrations of the HIV-1-infected partner.</p