Testing the Effectiveness of an Evidence-based Transdiagnostic Cognitive Behavioral Therapy Approach for Improving HIV Treatment Outcomes Among Violence-affected and Virally Unsuppressed Women in South Africa
Overview
- Phase
- Not Applicable
- Intervention
- CETA
- Conditions
- HIV/AIDS
- Sponsor
- Boston University
- Enrollment
- 399
- Locations
- 1
- Primary Endpoint
- 12 Month Viral Suppression
- Status
- Completed
- Last Updated
- 2 months ago
Overview
Brief Summary
This study will evaluate the impact of the Common Elements Treatment Approach (CETA), an evidence-based intervention comprised of cognitive-behavioral therapy elements, at improving HIV treatment outcomes among women with HIV who have experienced intimate partner violence (IPV) and have an unsuppressed viral load on HIV treatment. To evaluate CETA, the investigators will conduct a randomized controlled trial of HIV-infected women, with or without their partners, who have experienced IPV and have an unsuppressed viral load to test the effect of CETA in increasing viral suppression and reducing violence. The investigators will also identify mediators and moderators of CETA's effect on retention and viral suppression and assess the cost and cost-effectiveness of CETA vs. active control at increasing the proportion who are retained and virally suppressed by 12 months.
Detailed Description
There are just under one million people with HIV in South Africa who have initiated antiretroviral therapy (ART) but remain unsuppressed. South Africa has been making progress towards UNAIDS 90-90-90 targets but currently only 47% of those infected are suppressed. In South Africa, one major barrier to consistent treatment is intimate partner violence (IPV); nearly 50% of women have experienced IPV. The Common Elements Treatment Approach (CETA) is an evidence-based intervention intended to provide coping skills to women who have experienced IPV, and is comprised of cognitive-behavioral therapy elements. It is a transdiagnostic tool that can flexibly address a range of mental health problems (e.g. depression, anxiety) and represents the current best practice in global mental health as a more cost-effective, scalable and sustainable model. CETA is one of the most promising interventions to impact HIV outcomes through addressing the indirect effects of IPV on adherence and continuity of care. The investigators will conduct a randomized controlled trial of HIV-infected women, with or without their partners, who have experienced IPV and have an unsuppressed viral load to test the effect of CETA, in increasing retention and viral suppression, and reducing violence. The study aim is: • Among HIV-infected women on ART who have experienced IPV and have an unsuppressed viral load, assess the effectiveness of CETA vs. active control at increasing the proportion retained and virally suppressed by 12 months and at decreasing the severity and incidence of IPV and other mental and behavioral health problems using a randomized trial; Study staff will obtain full informed consent from those who meet inclusion criteria. For those that agree to participate, study staff will then randomize patients to CETA or control using sealed randomization envelopes. All subjects will be followed for 12 months to ensure data for primary and secondary outcomes is complete. Follow-up HIV data will be passive using routinely collected medical records from the clinics. HIV outcomes will be assessed at 3 and 12-months post-baseline. Questionnaires on violence, substance use, and mental health will be administered at baseline, and at 3 months (following CETA end) and 12 months post-baseline. These include: Severity of Violence Against Women Scale, Center for Epidemiological Studies-Depression Scale, Harvard Trauma Questionnaire, and Alcohol, Smoking, and Substance Involvement Screening Test. The primary outcome will be retention and viral suppression (\<50 copies/mL) by 12 months after randomization. Secondary outcomes will include: 1) Viral suppression at 3 months; 2) Attrition at 12 months; and 3) IPV, mental/behavioral health, alcohol and other substance use at 3 and 12 months. The primary aim is to analyze the impact of CETA in the full study population; however, our sample size was calculated to ensure our ability to detect differences separately among women who include a partner in the CETA intervention and those who do not not (noting that partners are not enrolled in the study, they are only enrolled in CETA and as such are not study subjects). A sample of 400 women will be included which will give us 80% power to detect an absolute 21% difference between arms. The primary analysis will be a comparison of intervention and control by risk differences with 95% confidence intervals. The investigators will analyze direct effects of CETA on continuous outcomes (e.g., mental health) with linear mixed models. The impact of potential moderators on retention and mental health outcomes using interaction terms will be assessed.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Adult HIV positive women
- •Initiated HIV treatment
- •Most recent viral load \>50 copies/mL or they have defaulted from treatment or had a missed or late (\>14 days) visit in the last year
- •Has experienced IPV in the past 12 months
- •Has their own phone and can receive text messages
- •Literate and able to speak and read one of: English, Zulu, SeSotho
- •If including a partner, the woman has disclosed HIV status to the partner that will be invited to participate (noting that male partners are not study subjects, only the woman is)
Exclusion Criteria
- •Unwilling to complete the informed consent process
- •Currently psychotic or on unstable psychiatric regimen
- •Suicide attempt/ideation with intent and plan, and/or self-harm in the past month
- •Enrolled in any other HIV treatment intervention study
Arms & Interventions
CETA (Common Elements Treatment Approach)
Participants randomized to CETA arm will meet weekly with a lay provider or community health worker member of the study staff for about an hour once each week, approximately 6-12 times depending on presentation and symptom level. This treatment arm will include Short Message Service (SMS) text reminders of their HIV care appointments, similar to the active control group. As of October 12, 2022 participants can elect to have CETA delivered by telephone.
Intervention: CETA
CETA (Common Elements Treatment Approach)
Participants randomized to CETA arm will meet weekly with a lay provider or community health worker member of the study staff for about an hour once each week, approximately 6-12 times depending on presentation and symptom level. This treatment arm will include Short Message Service (SMS) text reminders of their HIV care appointments, similar to the active control group. As of October 12, 2022 participants can elect to have CETA delivered by telephone.
Intervention: Short Message Service (SMS) text reminders
Active control
Participants randomized to the active control arm will receive usual care for intimate partner violence. Short Message Service (SMS) text messages will be sent monthly to our control group participants to remind them of HIV care appointments.
Intervention: Short Message Service (SMS) text reminders
Outcomes
Primary Outcomes
12 Month Viral Suppression
Time Frame: 12 months post randomization
The proportion of participants who are virally suppressed (\<50 copies/mL) by 12 months post randomization
Secondary Outcomes
- 3 Month Viral Suppression(3 months post randomization)
- 12 Month Attrition Rate(12 months post randomization)
- Violence Against Women at 3 Months(3 months)
- Violence Against Women at 12 Months(12 months)
- Substance Use at 3 Months(3 months)
- Substance Use at 12 Months(12 months)
- Post-traumatic Stress Disorder (PTSD) Symptoms at 3 Months(3 months)
- Post-traumatic Stress Disorder (PTSD) Symptoms at 12 Months(12 months)
- Depression Based on the Epidemiological Studies-Depression Scale (CES-D) Scale Score at 3 Months(3 months)
- Depression Based on the Epidemiological Studies-Depression Scale (CES-D) Scale Score at 12 Months(12 months)