Implementation Research for Vulnerable Women in South Africa

NCT02733003 | Completed

• 1 other identifier: R01AA022882
• Study Type: interventional
• Target: 564
• Locations: 2 countries
• Sites: 2

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.

Conditions

HIV; Substance Abuse

Keywords

Implementation Science; HIV; Sexual Risk; Sexually Transmitted Diseases; Substance Abuse; Violence and Victimization; Linkage to care; Gender-based Violence; Antiretroviral Therapy (ART)

Outcome Measures

Primary Outcomes (16)

• 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 Outcomes (20)

• Antiretroviral Therapy (ART) Initiation and Adherence

  Baseline

• Antiretroviral Therapy (ART) Initiation and Adherence

  6 months post-enrollment

• Alcohol Use - self-reported frequency and amount

  Baseline

• Alcohol Use - self-reported frequency and amount

  6 months post-enrollment

• Alcohol Use

  Baseline

Study Arms (1)

Women's Health CoOp (WHC)

EXPERIMENTAL

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)

Interventions

Women's Health CoOp (WHC) BEHAVIORAL

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.

Women's Health CoOp (WHC)

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• HIV/antenatal clinic or substance abuse treatment clinic
• Located in townships surrounding Cape Town
• Willing to take part in study
• Female;
• 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.

You may not qualify if:

• Not HIV Positive
• Not willing to do alcohol and drug screening

Sponsors & Collaborators

• RTI International: lead
• Kheth'Impilo: collaborator

Study Sites (2)

RTI International

Research Triangle Park, North Carolina, 27709, United States

Location

Kheth'Impilo

Cape Town, 8001, South Africa

Location

Related Publications (9)

• Wechsberg WM, Ndirangu JW, Speizer IS, Zule WA, Gumula W, Peasant C, Browne FA, Dunlap L. An implementation science protocol of the Women's Health CoOp in healthcare settings in Cape Town, South Africa: A stepped-wedge design. BMC Womens Health. 2017 Sep 18;17(1):85. doi: 10.1186/s12905-017-0433-8.

  PMID: 28923034 BACKGROUND

• Howard BN, Van Dorn R, Myers BJ, Zule WA, Browne FA, Carney T, Wechsberg WM. Barriers and facilitators to implementing an evidence-based woman-focused intervention in South African health services. BMC Health Serv Res. 2017 Nov 21;17(1):746. doi: 10.1186/s12913-017-2669-2.

  PMID: 29157230 BACKGROUND

• Wechsberg WM, Browne FA, Ndirangu J, Bonner CP, Kline TL, Gichane M, Zule WA. Outcomes of Implementing in the Real World the Women's Health CoOp Intervention in Cape Town, South Africa. AIDS Behav. 2021 Dec;25(Suppl 3):276-289. doi: 10.1007/s10461-021-03251-7. Epub 2021 Apr 23.

  PMID: 33891233 RESULT

• Gichane MW, Wechsberg WM, Ndirangu J, Browne FA, Bonner CP, Grimwood A, Shaikh N, Howard B, Zule WA. Implementation science outcomes of a gender-focused HIV and alcohol risk-reduction intervention in usual-care settings in South Africa. Drug Alcohol Depend. 2020 Oct 1;215:108206. doi: 10.1016/j.drugalcdep.2020.108206. Epub 2020 Aug 1.

  PMID: 32771909 RESULT

• Browne FA, Gichane MW, Shangase N, Ndirangu J, Bonner CP, Wechsberg WM. Social Determinants of Alcohol and Other Drug Misuse Among Women Living with HIV in Economically Underserved Communities in Cape Town, South Africa: A Cross-Sectional Study. AIDS Behav. 2023 Apr;27(4):1329-1338. doi: 10.1007/s10461-022-03869-1. Epub 2022 Nov 7.

  PMID: 36344731 RESULT

• Gichane MW, Wechsberg WM, Ndirangu J, Howard B, Bonner CP, Browne FA, Zule WA. Sustainability of a gender-focused HIV and alcohol risk-reduction intervention in usual care settings in South Africa: a mixed methods analysis. AIDS Care. 2021 Jan-Dec;33(sup1):11-17. doi: 10.1080/09540121.2021.1966694. Epub 2021 Sep 19.

  PMID: 34538158 RESULT

• Ndirangu JW, Gichane MW, Browne FA, Bonner CP, Zule WA, Cox EN, Smith KM, Carney T, Wechsberg WM. 'We have goals but [it is difficult]'. Barriers to antiretroviral therapy adherence among women using alcohol and other drugs living with HIV in South Africa. Health Expect. 2022 Apr;25(2):754-763. doi: 10.1111/hex.13422. Epub 2022 Jan 21.

  PMID: 35060260 RESULT

• Washio Y, Browne FA, Ndirangu J, Kline TL, Wechsberg WM. Antiretroviral Therapy (ART) Adherence and Prenatal Alcohol Use among Women Who Are Pregnant with HIV in South Africa. Int J Environ Res Public Health. 2021 Jul 13;18(14):7446. doi: 10.3390/ijerph18147446.

  PMID: 34299897 RESULT

• Wechsberg WM, Browne FA, Bonner CP, Washio Y, Howard BN, van der Drift I. Current Interventions for People Living with HIV Who Use Alcohol: Why Gender Matters. Curr HIV/AIDS Rep. 2021 Aug;18(4):351-364. doi: 10.1007/s11904-021-00558-x. Epub 2021 Jun 10.

  PMID: 34110591 RESULT

MeSH Terms

Conditions

Substance-Related Disorders; Sexually Transmitted Diseases

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders; Communicable Diseases; Infections; Genital Diseases; Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Felicia Browne, ScD

  RTI International

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 21, 2016
• First Posted: April 11, 2016
• Study Start: September 1, 2015
• Primary Completion: December 4, 2018
• Study Completion: December 4, 2018
• Last Updated: January 8, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share

Locations

US (1); ZA (1)