Last updated on June 2019

Implementation Research for Vulnerable Women in South Africa

Brief description of study

This study seeks to implement the Women's Health CoOp (Cooperative) (WHC) intervention into HIV treatment centers (HCT), antenatal, and substance treatment clinics in South Africa to translate the evidence-based intervention into real-world settings. Implementation, service, and patient outcomes will be evaluated through an iterative stepped wedge design.

Detailed Study Description

This five-year implementation science study is using cluster-randomized stepped-wedge design to evaluate the implementation, service, and patient outcomes associated with the WHC for alcohol and other drug (AOD)-using HIV positive women in usual care settings.

A list of four substance use treatment clinics and four HTC/healthcare clinics, which have been identified and approved by the City of Cape Town, South Africa will be randomized to begin the intervention during one of the four cycles. Each HTC/healthcare clinic will be paired with a substance rehab center based on geographic proximity, and each pair was randomized by computer into four succeeding 6-month implementation cycles where implementation of the WHC is taking place simultaneously at the paired sites. Up to 120 HIV positive participants will be recruited in each cycle (60 from each clinic) for the patient level outcomes.

Both qualitative and quantitative data will be collected to assess the appropriateness of marketing plans developed through formative methods, as well as the acceptability, adoption, feasibility, fidelity, and sustainability of the WHC intervention implementation as well as service outcomes (comprehensive services and timely service linkages) during each implementation cycle.

Each implementation cycle will last 6 months, with a "1-month formative lesson learned" evaluation. Subsequently, we will collect post-intervention data from each cycle. The process repeats itself over each cycle and these formative periods between cycles will be used to inform backward- and forward- implementation strategies, make modifications to the WHC, and leave time for site-specific training for the next cycle. Consequently, the sites randomized to the first cycle will have the longest post-intervention observation period whose implementation sustainability will be checked through fidelity forms and sustainability questionnaires, and sites in fourth cycle will benefit the most from the pre-intervention data because of lessons learned and information shared in pre-focus groups.

The intervention will be implemented in a group, however there may be instances when only one participant is available and therefore the intervention will be implemented one-on-one. The WHC has previously been tested in group and one-on-one formats and both have demonstrated consistent significant intervention effects. Research staff will train clinic staff members to deliver the intervention. The intervention will be delivered by clinic staff and will not be part of the research. The research questions are related to the feasibility of implementing the intervention in clinics and its acceptability to clinic staff and patients. We will collect information on patient-level outcomes to determine if the intervention is effective when it is delivered by clinic staff to patients in the clinic. Also, to assess acceptability of the intervention sessions among patients, we will conduct post-implementation focus groups with a randomly selected sub-sample of participants who participated in the intervention and completed their final 6-month appointment in each implementation cycle.

Implementation of the WHC in usual care settings has the potential to reach more vulnerable women and could have a high public health impact if implementation is shown to be effective and sustainable in these real-world settings.

Clinical Study Identifier: NCT02733003

Recruitment Status: Closed

Brief Description Eligibility Contact Research Team

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