Implementation Research for Vulnerable Women in South Africa

Study Overview
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Brief Summary
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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
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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.

Official Title
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Implementation Research for Vulnerable Women in South Africa

Conditions
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Substance Abuse, HIV

Intervention / Treatment
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* Behavioral: Women's Health CoOp (WHC)


Participation Criteria
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Eligibility Criteria
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Clinic Inclusion Criteria: HIV/antenatal clinic or substance abuse treatment clinic Located in townships surrounding Cape Town Willing to take part in study Patient Inclusion Criteria: Female; 18 to 45 years of age; Reports use of at least one drug, including alcohol, at least weekly during the previous 3 months; Reports unprotected sex with a male partner in the past 6 months; Has a positive HIV test result from either the participating health clinic or rehab clinic, or a clinic issued ARV card or ARV medication as proof of positive status; Reports the intention to remain in the area for at least the next 6 months; Provides informed consent to participate. Patient Exclusion Criteria: Not HIV Positive Not willing to do alcohol and drug screening

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Women's Health CoOp (WHC)<br>This is an adapted behavioral intervention for women in South Africa, who use alcohol and other drugs and are living with HIV or at risk of acquiring HIV. | Behavioral: Women's Health CoOp (WHC)<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Implementation and Service Outcomes: Readiness for appropriate change (appropriateness) | Explore perceived appropriateness of implementing the intervention through qualitative focus groups with clinic staff and patients | Baseline | 
| Implementation and Service Outcomes: Readiness for appropriate change (appropriateness) | Explore perceived appropriateness of implementing the intervention through qualitative focus groups with clinic staff and patients | 6-months post-enrollment | 
| Implementation and Service Outcomes: Readiness for appropriate change (appropriateness) | Explore perceived appropriateness of implementing the intervention through clinic staff survey | Baseline | 
| Implementation and Service Outcomes: Acceptability of the Women's Health CoOp (WHC) intervention | Assess perceived acceptability through qualitative focus groups with clinic staff and patients | Baseline | 
| Implementation and Service Outcomes: Acceptability of the Women's Health CoOp (WHC) intervention | Assess perceived acceptability through qualitative focus groups with clinic staff and patients | 6-months post-enrollment | 
| Implementation and Service Outcomes: Acceptability of the Women's Health CoOp (WHC) intervention | Assess perceived acceptability through patient interviews | Baseline | 
| Implementation and Service Outcomes: Acceptability of the Women's Health CoOp (WHC) intervention | Assess perceived acceptability through patient interviews | 6-months post-enrollment | 
| Implementation and Service Outcomes: Acceptability of the Women's Health CoOp (WHC) intervention | Assess perceived acceptability through clinic staff survey | Baseline | 
| Implementation and Service Outcome: Adoption of the Women's Health CoOp (WHC) intervention | Assess adoption of the intervention through qualitative focus groups with clinic staff. | Baseline | 
| Implementation and Service Outcome: Adoption of the WHC intervention | Assess adoption of the intervention through qualitative focus groups with clinic staff. | 6-months post-enrollment | 
| Implementation and Service Outcome: Cost | Assess start up and ongoing implementation costs | Baseline | 
| Implementation and Service Outcome: Cost | Assess start up and ongoing implementation costs | 6-months post-enrollment | 
| Implementation and Service Outcome: Feasibility | Exposure as measured by the ratio of the number of intervention workshops delivered to participants (a total of two across the intervention window) (compared to the total expected intervention visits. Acceptable retention measured at ≥85% of patients who complete both workshops within the intervention window. | Throughout the period of the study, up to a maximum of one year | 
| Implementation and Service Outcome: Fidelity | Observation: fidelity item scores where a 90% or above fidelity rating will indicate acceptable fidelity | Throughout the study at bimonthly intervals for up to one year | 
| Implementation and Service Outcomes: Sustainability | Examine sustainability through qualitative focus groups with clinic staff | Throughout the period of the study, up to a maximum of one year | 
| Implementation and Service Outcomes: Sustainability | Examine sustainability with clinic staff using an adapted TCU Workshop Assessment Follow-up Scale | 6 months post-intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Antiretroviral Therapy (ART) Initiation and Adherence | Number of participants that received clinical staging, were prescribed and initiated on antiretroviral therapy (ART) and were adhering to ART. | Baseline | 
| Antiretroviral Therapy (ART) Initiation and Adherence | Number of participants that received clinical staging, were prescribed and initiated on antiretroviral therapy (ART) and were adhering to ART. | 6 months post-enrollment | 
| Alcohol Use - self-reported frequency and amount | Participants' self-reported frequency and amount of alcohol use will be used to assess recent alcohol use. | Baseline | 
| Alcohol Use - self-reported frequency and amount | Participants' self-reported frequency and amount of alcohol use will be used to assess recent alcohol use. | 6 months post-enrollment | 
| Alcohol Use | Breathalyzer test results will be used to assess recent alcohol use. | Baseline | 
| Alcohol Use | Breathalyzer test results will be used to assess recent alcohol use. | 6 months post-enrollment | 
| Substance Use | Participants' frequency of benzodiazepines, cocaine, methamphetamine, MDMA, marijuana, and/or mandrax use will be used to assess recent substance use. | Baseline | 
| Substance Use | Participants' frequency of benzodiazepines, cocaine, methamphetamine, MDMA, marijuana, and/or mandrax use will be used to assess recent substance use. | 6-months post-enrollment | 
| Substance use | Urine drug screen test results will be used to assess recent use of drugs (benzodiazepines, cocaine, methamphetamine, MDMA, marijuana, and/or mandrax). | Baseline | 
| Substance use | Urine drug screen test results will be used to assess recent use of drugs (benzodiazepines, cocaine, methamphetamine, MDMA, marijuana, and/or mandrax). | 6-months post-enrollment | 
| Sexual Risk | Participants' self-reported frequency of condom use. | Baseline | 
| Sexual Risk | Participants' self-reported frequency of condom use. | 6-months post-enrollment | 
| Sexual Risk | Participants' self-reported number of sex partners. | Baseline | 
| Sexual Risk | Participants' self-reported number of sex partners. | 6-months post-enrollment | 
| Violence/Victimization | Percentages of participants who report being beaten, attacked with a weapon, or forced to have sex. | Baseline | 
| Violence/Victimization | Percentages of participants who report being beaten, attacked with a weapon, or forced to have sex. | 6-months post-enrollment | 
| Sexual Communication | The extent to which women have the skills to discuss sexual topics with their partners | Baseline | 
| Sexual Communication | The extent to which women have the skills to discuss sexual topics with their partners | 6-months post-enrollment | 
| Relationship Power | The extent to which women and their partners can equitably make decisions together as measured by the Relationship Power Scale (RPS) | Baseline | 
| Relationship Power | The extent to which women and their partners can equitably make decisions together as measured by the Relationship Power Scale (RPS) | 6-months post-enrollment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Implementation Science, Sexual Risk, Sexually Transmitted Diseases, Substance Abuse, Violence and Victimization, Linkage to care, Gender-based Violence, Antiretroviral Therapy (ART), HIV