Clinical trial NCT04242992: Effectiveness of Transdiagnostic Cognitive Behavioral Therapy for Improving HIV Treatment Outcomes in South Africa
Official title: 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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: HIV/AIDS
Violence
Keywords: HIV
Retention
Viral suppression
Violence
Cognitive behavioral therapy (CBT)
Common Elements Treatment Approach (CETA)
Lead sponsor: Boston University
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2020-01-27
Enrollment: 400
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Women will be randomized 1:1 to either CETA or an active attention control arm.
Primary purpose: SUPPORTIVE_CARE

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 has three aims:

* Aim 1: 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 an individually randomized trial;
* Aim 2: To identify mediators and moderators of CETA's effect on the primary outcome (retention and viral suppression);
* Aim 3: To assess the cost and cost-effectiveness of CETA vs. active control at increasing the proportion who are retained and virally suppressed by 12 months.

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 24 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-, 12- and 24-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 and 24 months; 2) Attrition at 12 and 24 months; 3) IPV, mental/behavioral health, alcohol and other substance use at 3 and 12 months; and 4) Cost and cost-effectiveness of the intervention.

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. 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. Micro costing methods will be used to cost all resources utilized and the cost effectiveness of CETA achieving the primary outcome will be evaluated.

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

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

Primary outcomes:
measure: 12 month viral suppression
timeFrame: 12 months post randomization
Secondary outcomes:
measure: 3 month viral suppression
timeFrame: 3 months post randomization
measure: 24 month viral suppression
timeFrame: 24 months post randomization
measure: 12 month attrition rate
timeFrame: 12 months post randomization
measure: 24 month attrition rate
timeFrame: 24 months post randomization
measure: Change in violence against women from baseline to 3 months
timeFrame: Baseline to 3 months
measure: Change in violence against women from baseline to 12 months
timeFrame: Baseline to 12 months
measure: Change in substance use from baseline to 3 months
timeFrame: Baseline to 3 months
measure: Change in substance use from baseline to 12 months
timeFrame: Baseline to 12 months
measure: Change in post-traumatic stress disorder (PTSD) symptoms from baseline to 3 months
timeFrame: Baseline to 3 months
measure: Change in post-traumatic stress disorder (PTSD) symptoms from baseline to 12 months
timeFrame: Baseline to 12 months
measure: Change in Center for Epidemiological Studies-Depression Scale (CES-D) scale score from baseline to 3 months
timeFrame: Baseline to 3 months
measure: Change in Center for Epidemiological Studies-Depression Scale (CES-D) scale score from baseline to 12 months
timeFrame: Baseline to 12 months
measure: Cost-effectiveness
timeFrame: 12 months
Other outcomes:
Locations:
city: Johannesburg
country: South Africa
facility: HIV Clinic
state: Gauteng
Study officials:
affiliation: Boston University
name: Matthew Fox, DSc
role: PRINCIPAL_INVESTIGATOR
References: