Clinical trial NCT02733003: Implementation Research for Vulnerable Women in South Africa
Official title: Implementation Research for Vulnerable Women in South Africa
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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)
Lead sponsor: RTI International
Sponsor class: OTHER
Collaborators: name: Kheth'Impilo
First posted: 2016-04-11
Enrollment: 564
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility 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 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

Primary outcomes:
measure: Implementation and Service Outcomes: Readiness for appropriate change (appropriateness)
timeFrame: Baseline
measure: Implementation and Service Outcomes: Readiness for appropriate change (appropriateness)
timeFrame: 6-months post-enrollment
measure: Implementation and Service Outcomes: Readiness for appropriate change (appropriateness)
timeFrame: Baseline
measure: Implementation and Service Outcomes: Acceptability of the Women's Health CoOp (WHC) intervention
timeFrame: Baseline
measure: Implementation and Service Outcomes: Acceptability of the Women's Health CoOp (WHC) intervention
timeFrame: 6-months post-enrollment
measure: Implementation and Service Outcomes: Acceptability of the Women's Health CoOp (WHC) intervention
timeFrame: Baseline
measure: Implementation and Service Outcomes: Acceptability of the Women's Health CoOp (WHC) intervention
timeFrame: 6-months post-enrollment
measure: Implementation and Service Outcomes: Acceptability of the Women's Health CoOp (WHC) intervention
timeFrame: Baseline
measure: Implementation and Service Outcome: Adoption of the Women's Health CoOp (WHC) intervention
timeFrame: Baseline
measure: Implementation and Service Outcome: Adoption of the WHC intervention
timeFrame: 6-months post-enrollment
measure: Implementation and Service Outcome: Cost
timeFrame: Baseline
measure: Implementation and Service Outcome: Cost
timeFrame: 6-months post-enrollment
measure: Implementation and Service Outcome: Feasibility
timeFrame: Throughout the period of the study, up to a maximum of one year
measure: Implementation and Service Outcome: Fidelity
timeFrame: Throughout the study at bimonthly intervals for up to one year
measure: Implementation and Service Outcomes: Sustainability
timeFrame: Throughout the period of the study, up to a maximum of one year
measure: Implementation and Service Outcomes: Sustainability
timeFrame: 6 months post-intervention
Secondary outcomes:
measure: Antiretroviral Therapy (ART) Initiation and Adherence
timeFrame: Baseline
measure: Antiretroviral Therapy (ART) Initiation and Adherence
timeFrame: 6 months post-enrollment
measure: Alcohol Use - self-reported frequency and amount
timeFrame: Baseline
measure: Alcohol Use - self-reported frequency and amount
timeFrame: 6 months post-enrollment
measure: Alcohol Use
timeFrame: Baseline
measure: Alcohol Use
timeFrame: 6 months post-enrollment
measure: Substance Use
timeFrame: Baseline
measure: Substance Use
timeFrame: 6-months post-enrollment
measure: Substance use
timeFrame: Baseline
measure: Substance use
timeFrame: 6-months post-enrollment
measure: Sexual Risk
timeFrame: Baseline
measure: Sexual Risk
timeFrame: 6-months post-enrollment
measure: Sexual Risk
timeFrame: Baseline
measure: Sexual Risk
timeFrame: 6-months post-enrollment
measure: Violence/Victimization
timeFrame: Baseline
measure: Violence/Victimization
timeFrame: 6-months post-enrollment
measure: Sexual Communication
timeFrame: Baseline
measure: Sexual Communication
timeFrame: 6-months post-enrollment
measure: Relationship Power
timeFrame: Baseline
measure: Relationship Power
timeFrame: 6-months post-enrollment
Other outcomes:
Locations:
city: Research Triangle Park
country: United States
facility: RTI International
state: North Carolina
city: Cape Town
country: South Africa
facility: Kheth'Impilo
Study officials:
affiliation: RTI International
name: Felicia Browne, ScD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.