Randomized Controlled Trial of Interpersonal Psychotherapy for Depression and PTSD Among HIV+ Women in Kenya

Study Overview
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Brief Summary
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The aim of this study is to conduct a 12-week IPT+TAU versus wait list TAU in a cohort of HIV+GBV+ women in Nyanza Province to relieve depression and PTSD and improve ARV adherence. This pilot study will provide data on the efficacy trends, acceptability and feasibility of our IPT intervention and will generate preliminary findings for an R01-funded intervention to test the intervention's efficacy for remediating the effects of GBV trauma on mental health and HIV-related outcomes. Hypothesis 1: IPT+ TAU will be more effective for reduction of depression and PTSD than TAU alone. Hypothesis 2: IPT+TAU will be acceptable and feasible.

Detailed Description
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We will use a parallel design with FACES Treatment as Usual (TAU) control to provide IPT once per week for twelve weeks to HIV+GBV+ women meeting CIDI diagnostic criteria for depression (MDD, dysthymia, minor depression) and PTSD secondary to GBV. Blocked randomization will be used to evenly distribute 120 participants to (1) IPT + TAU or (2) TAU for 12 weeks. The TAU group will be offered IPT treatment following the initial 12 week trial. Thus, all study subjects will receive TAU throughout the study and they will all receive IPT in either the first or second half of the study. My research team at FACES will be recruited for IPT training as potential therapists in the IPT pilot. A run-in study design will be used, assigning one training case apiece to each of the 8 therapists to practice IPT skills. Both IPT + TAU and TAU groups will be measured at baseline and weeks 12, 24 and 36 by blinded assessment. At FACES, TAU resources for HIV+GBV+ women include medical professionals, counseling, community elders, church leaders, police, and a pro-bono legal aid, all of who have all been involved with past FACES GBV interventions.

Official Title
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Randomized Controlled Trial of Interpersonal Psychotherapy for Depression and PTSD Among HIV-infected Women Exposed to Gender Based Violence in Kenya

Conditions
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Depression, Posttraumatic Stress Disorder, HIV

Intervention / Treatment
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* Behavioral: interpersonal psychotherapy
* Behavioral: treatment as usual


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: .(1) HIV+ women enrolled at FACES-Kisumu; (2) Diagnosis with depression (MDD, dysthymia, minor depression) and PTSD secondary to GBV* on the CIDI; (3) Ability to attend weekly therapy sessions and repeated measures; (4) Age greater than 18 years; (5) Ability to give informed consent. Exclusion Criteria: (1) Cognitive dysfunction requiring a higher level of care or compromising ability to participate in IPT**; (2) severe thought or mood disorder symptoms requiring a higher level of care or interfering with ability to participate in IPT; (3) current drug and alcohol dependence requiring substance use treatment. Although PTSD is associated with substance abuse in EuroAmerican populations, a recent study of 5175 FACES patients found that over 80% of this LMIC population use no alcohol.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: treatment as usual<br>Usual Clinic psychosocial treatment | Behavioral: treatment as usual<br>* Clinic psychosocial treatment as usual<br>|
| Experimental: interpersonal psychotherapy<br>Interpersonal Psychotherapy is an evidence-based structured, brief psychotherapy which focuses on improving relationships in order to improve mood and reduce anxiety. | Behavioral: interpersonal psychotherapy<br>* Interpersonal psychotherapy is an evidence based, structured, brief psychotherapy which improves relationships in order to improve mood and reduce anxiety<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Depression, PTSD | structured clinical interview: Composite International Diagnostic Interview (CIDI) | Change from 0-12 weeks, 12-24 weeks and 24-36 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ARV adherence | Visual Analog Scale self-report | Change from 0-12 weeks, 12-24 weeks and 24-36 weeks | 
| HIV viral load | blood draw | 12 weeks, 24 weeks, 36 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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interpersonal psychotherapy, HIV, women, gender based violence, mental health, africa, kenya, global mental health, HIV treatment adherence