Implementation Research for Vulnerable Women in South Africa
Condition: HIV; Substance Abuse
MeSH terms: Substance-Related Disorders
Study type: Interventional

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

Detailed description: 
      This five-year implementation science study used a 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 healthcare clinics, identified and
      approved by the City of Cape Town, South Africa were randomized to begin the intervention
      during one of the four cycles. Each healthcare clinic was paired with a substance use
      treatment clinic based on geographic proximity, and each pair was randomized by computer into
      four succeeding 6-month implementation cycles where implementation of the WHC took place
      simultaneously at the paired sites. Approximately 120 HIV positive participants were
      recruited in each cycle (approximately 60 from each clinic) for the patient level outcomes.

      Both qualitative and quantitative data were 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 included a pre-implementation period, implementation period
      (6-months), and post-implementation period. In the pre-implementation period, focus groups
      and questionnaires surveys were conducted with clinic staff to assess the readiness of each
      site to implement the WHC. During the implementation period, employees at each site were
      trained to facilitate the WHC and the WHC was integrated into site operations. Subsequently,
      in the post-implementation period the researchers collected data related to challenges,
      benefits, and sustainability from each site. The process was repeated for each cycle and
      these formative periods between cycles were 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 had the
      longest post-intervention observation period whose implementation sustainability was checked
      through fidelity forms and sustainability questionnaires, and sites in the fourth cycle
      benefited the most because of lessons learned and information shared from previous cycles.

      The intervention was implemented in a group, however there were instances when only one
      participant was available and therefore the intervention was 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 trained clinic staff members to
      deliver the intervention. The intervention was delivered by clinic staff and was not part of
      the research. The research questions were related to the feasibility of implementing the
      intervention in clinics and its acceptability to clinic staff and patients. The researchers
      collected information on patient-level outcomes to determine if the intervention was
      effective when it was delivered by clinic staff to patients in the clinic. Also, to assess
      acceptability of the intervention workshops among patients, the researchers conducted
      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.
    

Intervention name(s): Women's Health CoOp (WHC)
Intervention type(s): Behavioral
Intervention description(s): Participants in this group will participate in two workshops of the woman-focused intervention about HIV/STIs, sexual behaviors, alcohol and other drug use, violence, communication skills, and other issues.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Implementation Science; HIV; Sexual Risk; Sexually Transmitted Diseases; Substance Abuse; Violence and Victimization; Linkage to care; Gender-based Violence; Antiretroviral Therapy (ART)