Study protocol: A randomised trial of the effectiveness of the Common Elements Treatment Approach (CETA) for improving HIV treatment outcomes among women experiencing intimate partner violence in South Africa.

INTRODUCTION: Intimate partner violence (IPV) is a barrier to consistent HIV treatment in South Africa. Previous trials have established that the Common Elements Treatment Approach (CETA), a cognitive-behavioural-based intervention, is effective in reducing mental and behavioural health problems but has not been trialled for effectiveness in improving HIV outcomes. This paper describes the protocol for a randomised trial that is testing the effectiveness of CETA in improving HIV treatment outcomes among women experiencing IPV in South Africa. METHODS AND ANALYSIS: We are conducting a randomised trial among HIV-infected women on antiretroviral therapy, who have experienced sexual and/or physical IPV, to test the effect of CETA on increasing retention and viral suppression and reducing IPV. Women living with HIV who have an unsuppressed viral load or are at high risk for poor adherence and report experiencing recent IPV, defined as at least once within in the last 12 months, will be recruited from HIV clinics and randomised 1:1 to receive CETA or an active attention control (text message reminders). All participants will be followed for 24 months. Follow-up HIV data will be collected passively using routinely collected medical records. HIV outcomes will be assessed at 12 and 24 months post-baseline. Questionnaires on violence, substance use and mental health will be administered at baseline, post-CETA completion and at 12 months post-baseline. Our primary outcome is retention and viral suppression (<50 copies/mL) by 12 months post-baseline. We will include 400 women which will give us 80% power to detect an absolute 21% difference between arms. Our primary analysis will be an intention-to-treat comparison of intervention and control by risk differences with 95% CIs. ETHICS AND DISSEMINATION: Ethics approval provided by University of the Witwatersrand Human Research Ethics Committee (Medical), Boston University Institutional Review Board and Johns Hopkins School Institutional Review Board. Results will be published in peer-reviewed journals. TRIAL REGISTRATION NUMBER: NCT04242992.

Voices from the front lines: A qualitative study of integration of HIV, tuberculosis, and primary healthcare services in Johannesburg, South Africa.

INTRODUCTION: In South Africa, in 2013-2014, provision of antiretroviral treatment (ART) shifted in some areas from NGOs to public facilities. Tuberculosis (TB) management has also been integrated into public services. We aimed to explore the opinions and experiences of service managers and healthcare providers regarding integration of HIV and TB services into primary healthcare services. METHODS: The study sites included three clinics in one peri-urban/urban administrative region of Johannesburg. From March 2015 to August 2016, trained interviewers conducted semi-structured interviews with purposively selected participants. Participants were eligible if they were city/regional managers, clinic managers, or healthcare providers responsible for HIV, TB, non-communicable diseases, or sexual and reproductive health at the three study sites. We used a grounded theory approach for iterative, qualitative analysis, and produced descriptive statistics for quantitative data. RESULTS: We interviewed 19 individuals (nine city/regional managers, three clinic managers, and seven nurses). Theoretical definitions of integration varied, as did actual practice. Integration of HIV treatment had been anticipated, but only occurred when required due to shifts in funding for ART. The change was rapid, and some clinics felt unprepared. That said, nearly all respondents were in favor of integrated care. Perceived benefits included comprehensive case management, better client-nurse interactions, and reduced stigma. Barriers to integration included staff shortages, insufficient training and experience, and outdated clinic infrastructure. There were also concerns about the impact of integration on staff workloads and waiting times. Finally, there were concerns about TB integration due to infection control issues. DISCUSSION: Integration is multi-faceted and often contingent on local, if not site-specific, factors. In the future in South Africa and in other settings contending with health service reorganization, staff consultations prior to and throughout phase-in of services changes could contribute to improved understanding of operational requirements, including staff needs, and improved patient outcomes.