Sinako, a study on HIV competent households in South Africa: a cluster-randomised controlled trial protocol

Trials. 2020 Feb 10;21(1):154. doi: 10.1186/s13063-020-4082-0.

Abstract

Background: With 7.7 million South Africans currently infected with human immunodeficiency virus (HIV) and 4.8 million currently receiving antiretroviral treatment (ART), the epidemic represents a considerable burden for the country's resource-limited health system. In response to the health and human resource shortages, task shifting to community health workers (CHWs) and empowering people living with HIV (PLWH) are integral parts of a sustainable ART strategy. Despite the success of the ART programme, South Africa still faces both prevention and treatment challenges. To tackle these challenges, future endeavours need to focus on the role played by the households of PLWH in mediating between the community and PLWH themselves. Building health-enabling "HIV competent" households with the capacity to actively stimulate lifestyles that foster health, offers a potential strategy to tackle South Africa's HIV-related challenges. The aim of the "Sinako: Households and HIV" study is to investigate to what extent and how an intervention can increase HIV competence in PLWH and their households, and subsequently optimise the impact of CHW support on individual ART outcomes.

Methods: The "Sinako" study is a cluster-randomised controlled trial with two arms. In the control arm, CHWs offer a standard package of support to PLWH during home visits, focused on the individual. The intervention arm includes both a focus on the individual and the household to enable the patient to self-manage their treatment within an HIV competent household. A longitudinal mixed methods design is adopted to analyse the data. For the quantitative data analysis, methods including latent cross-lagged modelling, multilevel modelling and logistic regression will be used. To assess the acceptability and feasibility of the intervention and to construct a comprehensive picture of the mechanisms underlying the impact on the household and the PLWH, qualitative data (in-depth interviews and focus group discussions) will be collected and analysed.

Discussion: Stimulating HIV competence in households could be a feasible and sustainable strategy to optimise the outcomes of CHW interventions and thus be important for HIV treatment interventions in resource-limited settings.

Trial registration: Pan African Clinical Trial Registry, PACTR201906476052236. Registered on 24 June 2019.

Keywords: Antiretroviral treatment; Cluster-randomised controlled trial; Community health workers; HIV competency; Household; People living with HIV; South Africa.

Publication types

  • Clinical Trial Protocol

MeSH terms

  • Adolescent
  • Adult
  • Aged
  • Aged, 80 and over
  • Anti-HIV Agents / therapeutic use
  • Awareness
  • Community Health Workers
  • Family Characteristics*
  • Female
  • Focus Groups
  • HIV Infections / drug therapy
  • HIV Infections / epidemiology*
  • HIV Infections / psychology*
  • HIV Infections / virology
  • HIV*
  • Health Behavior
  • House Calls
  • Humans
  • Male
  • Mental Competency / psychology*
  • Middle Aged
  • Randomized Controlled Trials as Topic
  • South Africa / epidemiology
  • Young Adult

Substances

  • Anti-HIV Agents