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Implementation Research for Vulnerable Women in South Africa

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ClinicalTrials.gov Identifier: NCT02733003
Recruitment Status : Recruiting
First Posted : April 11, 2016
Last Update Posted : August 29, 2017
Sponsor:
Collaborator:
Kheth'Impilo
Information provided by (Responsible Party):
RTI International

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
HIV Substance Abuse Behavioral: Women's Health CoOp (WHC) Not Applicable

Detailed 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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 714 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Implementation Research for Vulnerable Women in South Africa
Study Start Date : September 2014
Estimated Primary Completion Date : September 2018
Estimated Study Completion Date : September 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Women's Health CoOp (WHC)
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)
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. Personalized risk reduction action plans will be created at the end of the second intervention session.




Primary Outcome Measures :
  1. Implementation and Service Outcomes: Readiness for appropriate change (appropriateness) [ Time Frame: Baseline ]
    Explore perceived appropriateness of implementing the intervention using the Interventionist self-report (TCU Organizational Readiness for Change Scale)

  2. Implementation and Service Outcomes: Readiness for appropriate change (appropriateness) [ Time Frame: 6-month post-implementation of intervention ]
    Explore perceived appropriateness of implementing the intervention using the Interventionist self-report (TCU Organizational Readiness for Change Scale)

  3. Implementation and Service Outcomes: Acceptability of Women's Health CoOp (WHC) intervention [ Time Frame: Baseline ]
    Assess perceived acceptability through patient interviews using the Client Satisfaction Questionnaire-8

  4. Implementation and Service Outcomes: Acceptability of Women's Health CoOp (WHC) intervention [ Time Frame: 6-month post-implementation of intervention ]
    Assess perceived acceptability through patient interviews using the Client Satisfaction Questionnaire-8

  5. Implementation and Service Outcomes: Acceptability of WHC intervention [ Time Frame: Baseline ]
    Assess perceived acceptability through patient interviews using the Narrative Evaluation of Interventionist Interview

  6. Implementation and Service Outcomes: Acceptability of WHC intervention [ Time Frame: 6-month post-implementation of intervention ]
    Assess perceived acceptability through patient interviews using the Narrative Evaluation of Interventionist Interview

  7. Implementation and Service Outcomes: Acceptability of WHC intervention [ Time Frame: Baseline ]
    Assess perceived acceptability through interventionist self-report (TCU Workshop Assessment Follow-up Scale)

  8. Implementation and Service Outcomes: Acceptability of WHC intervention [ Time Frame: 6-month post-implementation of intervention ]
    Assess perceived acceptability through interventionist self-report (TCU Workshop Assessment Follow-up Scale)

  9. Implementation and Service Outcomes: Acceptability of WHC intervention [ Time Frame: Baseline ]
    Assess perceived acceptability through qualitative focus groups with clinicians, patients and administrators

  10. Implementation and Service Outcomes: Acceptability of WHC intervention [ Time Frame: 6-month post-implementation of intervention ]
    Assess perceived acceptability through qualitative focus groups with clinicians, patients and administrators

  11. Implementation and Service Outcome: Adoption of the WHC intervention [ Time Frame: Baseline ]
    Assess adoption of the intervention at both interventionist and clinic setting levels as measured by the ratio of settings that agree to participate (compared with the total number approached).

  12. Implementation and Service Outcome: Adoption of the WHC intervention [ Time Frame: 6-month post-implementation of intervention ]
    Assess adoption of the intervention at both interventionist and clinic setting levels as measured by the ratio of settings that agree to participate (compared with the total number approached).

  13. Implementation and Service Outcome: Adoption of the WHC intervention [ Time Frame: Baseline ]
    Assess adoption of the intervention at both interventionist and clinic setting levels as measured by the ratio of clinicians delivering the adapted intervention (compared with the total number of clinicians in the setting).

  14. Implementation and Service Outcome: Adoption of the WHC intervention [ Time Frame: 6-month post-implementation of intervention ]
    Assess adoption of the intervention at both interventionist and clinic setting levels as measured by the ratio of clinicians delivering the adapted intervention (compared with the total number of clinicians in the setting).

  15. Implementation and Service Outcome: Adoption of the WHC intervention [ Time Frame: Baseline ]
    Assess adoption of the intervention at both interventionist and clinic setting levels through self-report TCU Organizational Readiness for Change scale

  16. Implementation and Service Outcome: Adoption of the WHC intervention [ Time Frame: 6-month post-implementation of intervention ]
    Assess adoption of the intervention at both interventionist and clinic setting levels through self-report TCU Organizational Readiness for Change scale

  17. Implementation and Service Outcome: Adoption of the Intervention [ Time Frame: Baseline ]
    Assess adoption of the intervention at both interventionist and clinic setting levels through qualitative focus groups and surveys with clinicians, patients and administrators.

  18. Implementation and Service Outcome: Adoption of the Intervention [ Time Frame: 6-month post-implementation of intervention ]
    Assess adoption of the intervention at both interventionist and clinic setting levels through qualitative focus groups and surveys with clinicians, patients and administrators.

  19. Implementation and Service Outcome: Cost [ Time Frame: Baseline ]
    Assess start up and ongoing implementation costs using the Substance Abuse Services Cost Analysis Program Questionnaire (SASCAP)

  20. Implementation and Service Outcome: Cost [ Time Frame: 6-month post-implementation of intervention ]
    Assess start up and ongoing implementation costs using the Substance Abuse Services Cost Analysis Program Questionnaire (SASCAP)

  21. Implementation and Service Outcome: Feasibility as measured by exposure to the intervention [ Time Frame: Baseline ]
    Issues related to exposure as measured by the ratio of the number of intervention modules delivered to participants (a total of two across the intervention window) (compared to the total expected intervention visits)

  22. Implementation and Service Outcome: Feasibility as measured by exposure to the intervention [ Time Frame: 6-month post-implementation of intervention ]
    Issues related to exposure as measured by the ratio of the number of intervention modules delivered to participants (a total of two across the intervention window) (compared to the total expected intervention visits)

  23. Implementation and Service Outcome: Feasibility as measured by retention to the intervention [ Time Frame: Baseline ]
    Acceptable retention measured at ≥85% of patients who complete both modules within the intervention window)

  24. Implementation and Service Outcome: Feasibility as measured by retention to the intervention [ Time Frame: 6-month post-implementation of intervention ]
    Acceptable retention measured at ≥85% of patients who complete both modules within the intervention window)

  25. Implementation and Service Outcome: Feasibility as measured by coordination between the intervention and ART sites. [ Time Frame: Baseline ]
    Coordination measured by number and content of contacts between intervention and ARV providers

  26. Implementation and Service Outcome: Feasibility as measured by coordination between the intervention and ART sites. [ Time Frame: 6-month post-implementation of intervention ]
    Coordination measured by number and content of contacts between intervention and ARV providers

  27. Implementation and Service Outcome: Fidelity [ Time Frame: Bi-monthly after implementation of intervention up to study completion ]
    Fidelity item scores where 90% fidelity rating will indicate acceptable fidelity

  28. Implementation and Service Outcomes: Sustainability [ Time Frame: 6-month post-intervention implementation ]
    Examine sustainability using the TCU Workshop Assessment Follow-up Scale

  29. Implementation and Service Outcomes: Sustainability [ Time Frame: 12 months post-intervention and every 6 months thereafter up to study completion ]
    Examine sustainability using the TCU Workshop Assessment Follow-up Scale

  30. Implementation and Service Outcomes: Sustainability [ Time Frame: 6-month post-intervention implementation ]
    Examine sustainability through qualitative focus groups

  31. Implementation and Service Outcomes: Sustainability [ Time Frame: 12 months post-intervention and every 6 months thereafter up to study completion ]
    Examine sustainability through qualitative focus groups


Secondary Outcome Measures :
  1. Sexual Risk [ Time Frame: Baseline ]
    Self-reported frequency of condom use at last sex, self-reported number of sex partners over the past 6 months; self-reported number of concurrent sex partners as measured by the PRBA (WHC Pretoria Risk Behavior Assessment)

  2. Sexual Risk [ Time Frame: 6 Months post-intervention ]
    Self-reported frequency of condom use at last sex, self-reported number of sex partners over the past 6 months; self-reported number of concurrent sex partners as measured by the PRBA (WHC Pretoria Risk Behavior Assessment)

  3. Alcohol use [ Time Frame: Baseline ]
    Self -reported alcohol use in past 30 days and number of drinks consumed during the past 30 days as measured by RRBA (WHC Revised Risk Behavior Assessment)

  4. Alcohol use [ Time Frame: 6-months post-enrollment ]
    Self -reported alcohol use in past 30 days and number of drinks consumed during the past 30 days as measured by RRBA (WHC Revised Risk Behavior Assessment)

  5. Alcohol use [ Time Frame: Baseline ]
    Breathalyzer test results will be used to assess recent alcohol use.

  6. Alcohol use [ Time Frame: 6-month post-enrollment ]
    Breathalyzer test results will be used to assess recent alcohol use.

  7. Substance use [ Time Frame: Baseline ]
    Frequency of benzodiazepines, cocaine, methamphetamine, MDMA, marijuana, and/or mandrax use in the past 30 days as measured by WHC Pretoria Risk Behavior Assessment (PRBA)

  8. Substance use [ Time Frame: 6-month post-enrollment ]
    Frequency of benzodiazepines, cocaine, methamphetamine, MDMA, marijuana, and/or mandrax use in the past 30 days as measured by Pretoria Risk Behavior Assessment (PRBA)

  9. Substance use [ Time Frame: Baseline ]
    Frequency of benzodiazepines, cocaine, methamphetamine, MDMA, marijuana, and/or mandrax use in the past 30 days as measured by urine drug test to assess substance use

  10. Substance use [ Time Frame: 6-month post-enrollment ]
    Frequency of benzodiazepines, cocaine, methamphetamine, MDMA, marijuana, and/or mandrax use in the past 30 days as measured by urine drug test to assess substance use

  11. Violence/Victimization [ Time Frame: Baseline ]
    Percentages of participants who report being beaten, attacked with a weapon, or forced to have sex in the previous 90 days self-reported in the WHC Revised Risk Behavior Assessment (RRBA)

  12. Violence/Victimization [ Time Frame: 6-month post-enrollment ]
    Percentages of participants who report being beaten, attacked with a weapon, or forced to have sex in the previous 90 days self-reported in the WHC Revised Risk Behavior Assessment (RRBA)

  13. Communication [ Time Frame: Baseline ]
    The extent to which women have the skills to discuss sexual topics with their partners as measured by the Pretoria Risk Behavior Assessment (PRBA)

  14. Communication [ Time Frame: 6-month post-enrollment ]
    The extent to which women have the skills to discuss sexual topics with their partners as measured by the Pretoria Risk Behavior Assessment (PRBA)

  15. Relationship Power [ Time Frame: Baseline ]
    The extent to which women and their partners can equitably make decisions together as measured by the Relationship Power Scale (RPS)

  16. Relationship Power [ Time Frame: 6-month post-enrollment ]
    The extent to which women and their partners can equitably make decisions together as measured by the Relationship Power Scale (RPS)

  17. Medical evaluation initiation and treatment amongst HIV-positive [ Time Frame: Baseline ]
    Number of participants that received clinical staging, were prescribed and initiated on antiretroviral therapy (ART) and adhering to ART.

  18. Medical evaluation initiation and treatment amongst HIV-positive [ Time Frame: 6-month post-enrollment ]
    Number of participants that received clinical staging, were prescribed and initiated on antiretroviral therapy (ART) and adhering to ART.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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 the 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02733003


Contacts
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Contact: Wendee M Wechsberg, PhD 919-541-6422 wmw@rti.org

Locations
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United States, North Carolina
RTI International Recruiting
Research Triangle Park, North Carolina, United States, 27709
Contact: Wendee M Wechsberg, PhD    919-541-6422 ext 6422    wmw@rti.org   
South Africa
Kheth'Impilo Recruiting
Cape Town, South Africa, 8001
Contact: Ashraf Grimwood, MBChB, MPH    0861-543-844    Ashraf.grimwood@khethimpilo.org   
Sponsors and Collaborators
RTI International
Kheth'Impilo
Investigators
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Principal Investigator: Wendee M Wechsberg, PhD Director, RTI Global Gender Center

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: RTI International
ClinicalTrials.gov Identifier: NCT02733003     History of Changes
Other Study ID Numbers: R01AA022882 ( U.S. NIH Grant/Contract )
First Posted: April 11, 2016    Key Record Dates
Last Update Posted: August 29, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by RTI International:
Implementation Science
HIV
Sexual Risk
Sexually Transmitted Diseases
Substance Abuse
Violence and Victimization
Linkage to care
Gender-based Violence
Antiretroviral Therapy (ART)

Additional relevant MeSH terms:
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Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders