HIV Testing and Treatment with the Use of a Community Health Approach in Rural Africa

Abstract

Background: Universal antiretroviral therapy (ART) with annual population testing and a multidisease, patient-centered strategy could reduce new human immunodeficiency virus (HIV) infections and improve community health.

Methods: We randomly assigned 32 rural communities in Uganda and Kenya to baseline HIV and multidisease testing and national guideline-restricted ART (control group) or to baseline testing plus annual testing, eligibility for universal ART, and patient-centered care (intervention group). The primary end point was the cumulative incidence of HIV infection at 3 years. Secondary end points included viral suppression, death, tuberculosis, hypertension control, and the change in the annual incidence of HIV infection (which was evaluated in the intervention group only).

Results: A total of 150,395 persons were included in the analyses. Population-level viral suppression among 15,399 HIV-infected persons was 42% at baseline and was higher in the intervention group than in the control group at 3 years (79% vs. 68%; relative prevalence, 1.15; 95% confidence interval [CI], 1.11 to 1.20). The annual incidence of HIV infection in the intervention group decreased by 32% over 3 years (from 0.43 to 0.31 cases per 100 person-years; relative rate, 0.68; 95% CI, 0.56 to 0.84). However, the 3-year cumulative incidence (704 incident HIV infections) did not differ significantly between the intervention group and the control group (0.77% and 0.81%, respectively; relative risk, 0.95; 95% CI, 0.77 to 1.17). Among HIV-infected persons, the risk of death by year 3 was 3% in the intervention group and 4% in the control group (0.99 vs. 1.29 deaths per 100 person-years; relative risk, 0.77; 95% CI, 0.64 to 0.93). The risk of HIV-associated tuberculosis or death by year 3 among HIV-infected persons was 4% in the intervention group and 5% in the control group (1.19 vs. 1.50 events per 100 person-years; relative risk, 0.79; 95% CI, 0.67 to 0.94). At 3 years, 47% of adults with hypertension in the intervention group and 37% in the control group had hypertension control (relative prevalence, 1.26; 95% CI, 1.15 to 1.39).

Conclusions: Universal HIV treatment did not result in a significantly lower incidence of HIV infection than standard care, probably owing to the availability of comprehensive baseline HIV testing and the rapid expansion of ART eligibility in the control group. (Funded by the National Institutes of Health and others; SEARCH ClinicalTrials.gov number, NCT01864603.).

Figure 1.

Trial Cohort.

Figure 2.. HIV Testing, Uptake of Treatment, and Viral Suppression.

Panel A shows the cumulative percentage of residents who underwent human immunodeficiency virus (HIV) testing before and during the trial. The values labeled as “before baseline” are the percentages of the 138,052 residents (72,978 in the intervention group and 65,074 in the control group) who reported at the time of baseline testing that they had undergone previous HIV testing. The remaining values in Panel A are the percentages of all residents at the time of annual testing (excluding persons who migrated out of the community and persons who died and including persons who were newly 15 years of age and persons who migrated into the community, identified through the second census that was conducted at year 3) who had at least one documented HIV test result. At baseline, the assessment included 79,818 residents in the intervention group and 70,577 residents in the control group; at year 1, the assessment included 89,994 residents in the intervention group, and at year 2, the assessment included 93,008 residents in the intervention group. Panel B shows the percentage of persons who initiated antiretroviral therapy (ART) among HIV-infected persons with no previous or current ART use at baseline. The assessment included 3002 residents in the intervention group and 2950 residents in the control group. Community-level estimates of the probability of initiating ART by 6, 12, 24, and 36 months were calculated by the Kaplan–Meier method; data from patients who died or who migrated out of the community were censored at the time of death or out-migration. The trial groups were compared with the use of community-level targeted maximum likelihood estimation. Panel C shows population-level plasma HIV RNA suppression over time among HIV-infected residents. The assessment included all residents at the time of annual testing (excluding persons who migrated out of the community and persons who died, but including residents who were newly 15 years of age and those who migrated into the community, identified through the second census that was conducted at year 3). HIV RNA suppression was assessed in 5347 residents in the intervention group and in 4192 residents in the control group at baseline; in 6269 residents in the intervention group at year 1; in 6348 residents in the intervention group at year 2; and in 6800 residents in the intervention group and 6051 residents in the control group at year 3. Community-level estimates of suppression were adjusted for incomplete measures of HIV serostatus and HIV RNA with the use of individual-level targeted maximum likelihood estimation (adjustment variables included sex, age group, marital status, educational level, occupation, alcohol use, household wealth, mobility, previous HIV testing, and care status). The estimated total number of HIV-positive persons was 15,399 at baseline and was 15,748 at year 3. The trial groups were compared with the use of community-level targeted maximum likelihood estimation. I bars in Panels B and C indicate 95% confidence intervals.

Figure 3.. Incidence of Tuberculosis over Time.

Panel A shows the incidence rates of tuberculosis over time among residents who were HIV-positive at baseline and who had not received a diagnosis of active tuberculosis at baseline (13,430 residents). Panel B shows the incidence rates of tuberculosis over time among residents who were HIV-negative at baseline and who had not received a diagnosis of active tuberculosis at baseline (121,604 residents). For both analyses, data for person-time at risk were censored at the time of migration out of the community, death, or diagnosis of active tuberculosis, and the trial groups were compared at 3 years with the use of community-level targeted maximum likelihood estimation.