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Implementation Research for Vulnerable Women in South Africa

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02733003
Recruitment Status : Completed
First Posted : April 11, 2016
Last Update Posted : August 31, 2021
Sponsor:
Collaborator:
Kheth'Impilo
Information provided by (Responsible Party):
RTI International

Tracking Information
First Submitted Date  ICMJE January 21, 2016
First Posted Date  ICMJE April 11, 2016
Last Update Posted Date August 31, 2021
Actual Study Start Date  ICMJE September 2015
Actual Primary Completion Date December 4, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 9, 2019)
  • Implementation and Service Outcomes: Readiness for appropriate change (appropriateness) [ Time Frame: Baseline ]
    Explore perceived appropriateness of implementing the intervention through qualitative focus groups with clinic staff and patients
  • Implementation and Service Outcomes: Readiness for appropriate change (appropriateness) [ Time Frame: 6-months post-enrollment ]
    Explore perceived appropriateness of implementing the intervention through qualitative focus groups with clinic staff and patients
  • Implementation and Service Outcomes: Readiness for appropriate change (appropriateness) [ Time Frame: Baseline ]
    Explore perceived appropriateness of implementing the intervention through clinic staff survey
  • Implementation and Service Outcomes: Acceptability of the Women's Health CoOp (WHC) intervention [ Time Frame: Baseline ]
    Assess perceived acceptability through qualitative focus groups with clinic staff and patients
  • Implementation and Service Outcomes: Acceptability of the Women's Health CoOp (WHC) intervention [ Time Frame: 6-months post-enrollment ]
    Assess perceived acceptability through qualitative focus groups with clinic staff and patients
  • Implementation and Service Outcomes: Acceptability of the Women's Health CoOp (WHC) intervention [ Time Frame: Baseline ]
    Assess perceived acceptability through patient interviews
  • Implementation and Service Outcomes: Acceptability of the Women's Health CoOp (WHC) intervention [ Time Frame: 6-months post-enrollment ]
    Assess perceived acceptability through patient interviews
  • Implementation and Service Outcomes: Acceptability of the Women's Health CoOp (WHC) intervention [ Time Frame: Baseline ]
    Assess perceived acceptability through clinic staff survey
  • Implementation and Service Outcome: Adoption of the Women's Health CoOp (WHC) intervention [ Time Frame: Baseline ]
    Assess adoption of the intervention through qualitative focus groups with clinic staff.
  • Implementation and Service Outcome: Adoption of the WHC intervention [ Time Frame: 6-months post-enrollment ]
    Assess adoption of the intervention through qualitative focus groups with clinic staff.
  • Implementation and Service Outcome: Cost [ Time Frame: Baseline ]
    Assess start up and ongoing implementation costs
  • Implementation and Service Outcome: Cost [ Time Frame: 6-months post-enrollment ]
    Assess start up and ongoing implementation costs
  • Implementation and Service Outcome: Feasibility [ Time Frame: Throughout the period of the study, up to a maximum of one year ]
    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.
  • Implementation and Service Outcome: Fidelity [ Time Frame: Throughout the study at bimonthly intervals for up to one year ]
    Observation: fidelity item scores where a 90% or above fidelity rating will indicate acceptable fidelity
  • Implementation and Service Outcomes: Sustainability [ Time Frame: Throughout the period of the study, up to a maximum of one year ]
    Examine sustainability through qualitative focus groups with clinic staff
  • Implementation and Service Outcomes: Sustainability [ Time Frame: 6 months post-intervention ]
    Examine sustainability with clinic staff using an adapted TCU Workshop Assessment Follow-up Scale
Original Primary Outcome Measures  ICMJE
 (submitted: April 4, 2016)
  • Change in the perceived appropriateness of WHC intervention by interventionists [ Time Frame: 3 months ]
    Assessed by interventionist self-report using Texas Christian University Organizational Readiness for Change tool (TCU ORC)
  • Change in the perceived appropriateness of WHC intervention by interventionists [ Time Frame: 6 months ]
    Assessed by interventionist self-report using Texas Christian University Organizational Readiness for Change tool (TCU ORC)
  • Change in the perceived appropriateness of WHC intervention by interventionists and administrators [ Time Frame: 3 months ]
    Assessed by interventionist and administrator self-report using the TCU Post-training Workshop Evaluation tool (TCU WEVAL)
  • Change in the perceived appropriateness of WHC intervention by interventionists and administrators [ Time Frame: 6 months ]
    Assessed by interventionist and administrator self-report using the TCU Post-training Workshop Evaluation tool (TCU WEVAL)
  • Change in the perceived appropriateness of WHC intervention by clinicians, community women and administrators [ Time Frame: 3 months ]
    Obtain feedback using focus groups attended by clinicians, community women and administrators
  • Change in the perceived appropriateness of WHC intervention by clinicians, community women and administrators [ Time Frame: 6 months ]
    Obtain feedback using focus groups attended by clinicians, community women and administrators
  • Acceptability of WHC intervention by patients [ Time Frame: 6 months ]
    Acceptability by patients will be assessed using the Narrative Evaluation of Intervention Interview (NEII) for a randomly selected subsample of patients who participated in the intervention.
  • Acceptability of WHC intervention by patients [ Time Frame: 6 months ]
    Acceptability by patients will be assessed using the the Client Satisfaction Questionnaire - 8 (CSQ-8) for a randomly selected subsample of patients who participated in the intervention.
  • Change in the perceived acceptability of WHC intervention by interventionists (clinicians) [ Time Frame: 3 months ]
    Clinic Tracking Form - Delivery of intervention/total visits
  • Change in the perceived acceptability of WHC intervention by interventionists (clinicians) [ Time Frame: 6 months ]
    Clinic Tracking Form - Delivery of intervention/total visits
  • Change in the perceived acceptability of WHC intervention by setting (clinic) [ Time Frame: 3 months ]
    Intervention fidelity QA (quality assurance) checklist as completed by Study Coordinator
  • Change in the perceived acceptability of WHC intervention by setting (clinic) [ Time Frame: 6 months ]
    Intervention fidelity QA (quality assurance) checklist as completed by Study Coordinator
  • Change in the perceived acceptability of WHC intervention by clinicians, community women and administrators [ Time Frame: 3 months ]
    Obtain feedback using focus groups attended by clinicians, community women and administrators
  • Change in the perceived acceptability of WHC intervention by clinicians, community women and administrators [ Time Frame: 6 months ]
    Obtain feedback using focus groups attended by clinicians, community women and administrators
  • Adoption of WHC intervention by interventionists (clinicians) [ Time Frame: For three years ]
    Collect data on the ratio of number of interventionists participating/total number of interventionists approached as recorded in the Study Tracking Form
  • Adoption of WHC intervention by setting (clinic) [ Time Frame: For three years ]
    Collect data on the ratio of number of settings which agree to participate/total number of settings approached as recorded in the Study Tracking Form
  • Adoption of WHC intervention by interventionists (clinicians) [ Time Frame: Through study completion, up to three years ]
    Collect data on the ratio of interventionists using the WHC program/total number of interventionists in the setting
  • Adoption of WHC intervention by interventionists (clinicians) [ Time Frame: Every 6 months for three years ]
    Collect self-reporting data on the number of interventionists using the WHC intervention from interventionists at a follow-up meeting using the adoption-related items from the TCU Workshop Assessment
  • Change in the perceived adoption of WHC intervention by interventionists (clinicians) and administrators [ Time Frame: 3 months after implementation for a setting ]
    Collect adoption-relevant information at focus group meetings
  • Change in the perceived adoption of WHC intervention by interventionists [ Time Frame: 6 months after implementation for a setting ]
    Collect adoption-relevant information at focus group meetings
  • Start-up cost of WHC intervention [ Time Frame: 1 month after initial implementation ]
    Collect cost information using the Substance Abuse Services Cost Analysis Program Questionnaire (SASCAP)
  • Ongoing cost of WHC intervention [ Time Frame: Every 6 months for three years ]
    Collect cost information using the Substance Abuse Services Cost Analysis Program Questionnaire (SASCAP)
  • Feasibility of WHC implementation [ Time Frame: Every 6 months for three years ]
    Collect data on how many modules of the WHC intervention were received by patients within two weeks
  • Feasibility of WHC implementation [ Time Frame: Every 6 months for three years ]
    Collect data on number of referrals for clinical staging and subsequent ART (antiretroviral treatment) using clinic-based tracking forms and following NIH best-practice guidelines for integrating quantitative and qualitative data.
  • Feasibility of WHC implementation [ Time Frame: Every 6 months for three years ]
    Collect data on the feasibility of the study protocol by tracking the number of patients who are screened by the sites
  • Feasibility of WHC implementation [ Time Frame: Every 6 months for three years ]
    Collect data on the feasibility of the study protocol by tracking the number of patients who meet study criteria
  • Feasibility of WHC implementation [ Time Frame: Every 6 months for three years ]
    Collect data on the feasibility of the study protocol by tracking the number of patients who consent/refuse.
  • Feasibility of WHC intervention [ Time Frame: Every 6 months for three years ]
    Collect data on the number of enrolled participants who completed the intervention compared to those who did not
  • Fidelity to WHC intervention [ Time Frame: Every 6 months for three years ]
    Collect data using fidelity assessments using the WHC fidelity QA (quality assurance) checklist observer forms.
  • Penetration of the WHC intervention [ Time Frame: For up to three years ]
    Collect data using Woltmann's Index of Penetration to examine the number of patients receiving the adapted WHC intervention divided by the number of eligible patients.
  • Penetration of the WHC intervention [ Time Frame: For up to three years ]
    Collect data using Woltmann's Index of Penetration to examine the number of interventionists at a given setting who are delivering the WHC intervention versus the number who were trained to deliver the WHC intervention
  • Sustainability of the WHC intervention [ Time Frame: Every 6 months for one to three years ]
    Examine data on the number of patients treated at a setting collected on clinic tracking forms and referrals
  • Sustainability of the WHC intervention [ Time Frame: Every 6 months for one to three years ]
    Examine data on the transfer of funding from grant-based funding to permanent funding using data collected from the Texas Christian University Workshop Assessment at Follow-up (TCU WAFU)
  • Sustainability of the WHC intervention [ Time Frame: Every 6 months for one to three years ]
    Examine data on the transfer of funding from grant-based funding to permanent funding and routinization of WHC outreach workers to routine clinical care using data collected from the Texas Christian University Workshop Assessment at Follow-up (TCU WAFU)
  • Change in the perceived sustainability of the WHC intervention [ Time Frame: 3 months ]
    Obtain feedback using focus groups attended by clinicians and administrators
  • Change in the perceived sustainability of the WHC intervention [ Time Frame: 6 months ]
    Obtain feedback using focus groups attended by clinicians and administrators
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 10, 2019)
  • Antiretroviral Therapy (ART) Initiation and Adherence [ Time Frame: Baseline ]
    Number of participants that received clinical staging, were prescribed and initiated on antiretroviral therapy (ART) and were adhering to ART.
  • Antiretroviral Therapy (ART) Initiation and Adherence [ Time Frame: 6 months post-enrollment ]
    Number of participants that received clinical staging, were prescribed and initiated on antiretroviral therapy (ART) and were adhering to ART.
  • Alcohol Use - self-reported frequency and amount [ Time Frame: Baseline ]
    Participants' self-reported frequency and amount of alcohol use will be used to assess recent alcohol use.
  • Alcohol Use - self-reported frequency and amount [ Time Frame: 6 months post-enrollment ]
    Participants' self-reported frequency and amount of alcohol use will be used to assess recent alcohol use.
  • Alcohol Use [ Time Frame: Baseline ]
    Breathalyzer test results will be used to assess recent alcohol use.
  • Alcohol Use [ Time Frame: 6 months post-enrollment ]
    Breathalyzer test results will be used to assess recent alcohol use.
  • Substance Use [ Time Frame: Baseline ]
    Participants' frequency of benzodiazepines, cocaine, methamphetamine, MDMA, marijuana, and/or mandrax use will be used to assess recent substance use.
  • Substance Use [ Time Frame: 6-months post-enrollment ]
    Participants' frequency of benzodiazepines, cocaine, methamphetamine, MDMA, marijuana, and/or mandrax use will be used to assess recent substance use.
  • Substance use [ Time Frame: Baseline ]
    Urine drug screen test results will be used to assess recent use of drugs (benzodiazepines, cocaine, methamphetamine, MDMA, marijuana, and/or mandrax).
  • Substance use [ Time Frame: 6-months post-enrollment ]
    Urine drug screen test results will be used to assess recent use of drugs (benzodiazepines, cocaine, methamphetamine, MDMA, marijuana, and/or mandrax).
  • Sexual Risk [ Time Frame: Baseline ]
    Participants' self-reported frequency of condom use.
  • Sexual Risk [ Time Frame: 6-months post-enrollment ]
    Participants' self-reported frequency of condom use.
  • Sexual Risk [ Time Frame: Baseline ]
    Participants' self-reported number of sex partners.
  • Sexual Risk [ Time Frame: 6-months post-enrollment ]
    Participants' self-reported number of sex partners.
  • Violence/Victimization [ Time Frame: Baseline ]
    Percentages of participants who report being beaten, attacked with a weapon, or forced to have sex.
  • Violence/Victimization [ Time Frame: 6-months post-enrollment ]
    Percentages of participants who report being beaten, attacked with a weapon, or forced to have sex.
  • Sexual Communication [ Time Frame: Baseline ]
    The extent to which women have the skills to discuss sexual topics with their partners
  • Sexual Communication [ Time Frame: 6-months post-enrollment ]
    The extent to which women have the skills to discuss sexual topics with their partners
  • 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)
  • Relationship Power [ Time Frame: 6-months post-enrollment ]
    The extent to which women and their partners can equitably make decisions together as measured by the Relationship Power Scale (RPS)
Original Secondary Outcome Measures  ICMJE
 (submitted: April 4, 2016)
  • Sexual Risk [ Time Frame: 6 Month post-intervention ]
    Changes in behavior including condom use at last sex
  • Sexual Risk [ Time Frame: 6 Month post-intervention ]
    Changes in behavior including transactional sex
  • Sexual Risk [ Time Frame: 6 Months post-intervention ]
    Changes in behavior including # of sex partners
  • Sexual Risk [ Time Frame: 6 Months post-intervention ]
    Changes in behavior including number of concurrent sex partners
  • Alcohol use [ Time Frame: 6 months post-intervention ]
    Frequency of alcohol use in past 30 days and number of drinks consumed measured by RRBA (Revised Risk Behavior Assessment)
  • Substance use [ Time Frame: 6 months post-intervention ]
    Frequency of benzodiazepines, cocaine, methamphetamine, MDMA (methylenedioxymethamphetamine), marijuana and/or mandrax use in the past 30 days as measured by Pretoria Risk Behavior Assessment (PRBA).
  • Substance use [ Time Frame: 6 months post-intervention ]
    Frequency of benzodiazepines, cocaine, methamphetamine, MDMA (methylenedioxymethamphetamine), marijuana and/or mandrax use in the past 30 days as measured by self-report.
  • Substance use [ Time Frame: 6 months post-intervention ]
    Frequency of benzodiazepines, cocaine, methamphetamine, MDMA (methylenedioxymethamphetamine), marijuana and/or mandrax use in the past 30 days as measured by urine drug test.
  • Victimization [ Time Frame: 6 months post-intervention ]
    Percentages of women who report being beaten, attacked with a weapon or forced to have sex in the previous 90 days
  • Communication [ Time Frame: 6 months post-intervention ]
    Sexual discussion skills scale measured by PRBA (Pretoria Risk Behavior Assessment)
  • Relationship Power [ Time Frame: 6 months post-intervention ]
    Measured by RPS (Relationship Power Scale)
  • Medical evaluation initiation and treatment amongst HIV-positive women [ Time Frame: 6 months post-intervention ]
    Received clinical staging and CD4 (cluster of differentiation 4) count; prescribed ARV (antiretroviral) and adherence
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Implementation Research for Vulnerable Women in South Africa
Official Title  ICMJE Implementation Research for Vulnerable Women in South Africa
Brief 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Condition  ICMJE
  • HIV
  • Substance Abuse
Intervention  ICMJE 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.
Study Arms  ICMJE 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.
Intervention: Behavioral: Women's Health CoOp (WHC)
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 9, 2019)
564
Original Estimated Enrollment  ICMJE
 (submitted: April 4, 2016)
432
Actual Study Completion Date  ICMJE December 4, 2018
Actual Primary Completion Date December 4, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE South Africa,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02733003
Other Study ID Numbers  ICMJE R01AA022882( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Current Responsible Party RTI International
Original Responsible Party Same as current
Current Study Sponsor  ICMJE RTI International
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Kheth'Impilo
Investigators  ICMJE
Principal Investigator: Wendee M Wechsberg, PhD Principal Researcher and Director of Substance Use, Gender, and Applied Research (SUGAR Program, Director of RTI Global Gender Center
PRS Account RTI International
Verification Date June 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP