HIV prevention counseling intervention delivered during routine clinical care reduces HIV risk behavior in HIV-infected South Africans receiving antiretroviral therapy: The izindlela zokuphila/options for health randomized trial

Context: Sustainable interventions are needed to minimize HIV risk behavior among people living with HIV (PLWH) in South Africa on antiretroviral therapy (ART), a significant proportion of whom do not achieve viral suppression. Objective: To determine whether a brief lay counselor delivered intervention implemented during routine care can reduce risky sex among PLWH on ART. Design: Cluster-randomized 16 HIV clinical care sites in KwaZulu Natal, South Africa, to intervention or standard of care. Setting: Publicly funded HIV clinical care sites. Patients: One thousand eight hundred ninety-one PLWH on ART received the HIV prevention counseling intervention (n = 967) or standard-of-care counseling (n = 924). Intervention: Lay counselors delivered a brief intervention using motivational interviewing strategies based on the Information-Motivation-Behavioral (IMB) Skills model during routine clinical care. Main Outcome Measures: Number of sexual events without a condom in the past 4 weeks with partners of any HIV status, and with partners perceived to be HIV negative or HIV-status unknown, assessed at baseline, 6, 12, and 18 months. Results: Intervention participants reported significantly greater reductions in HIV risk behavior on both primary outcomes, compared with standard-of-care participants. Differences in sexually transmitted infection incidence between arms were not observed. Conclusions: Effective behavioral interventions, delivered by lay counselors within the clinical care setting, are consistent with the strategy of linking HIV care and HIV prevention and integrating biomedical and behavioral approaches to stemming the HIV epidemic. Trial Registration: Not applicable.