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Completed

NCT Number: NCT02320799

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

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.

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Key information

Conditions

Depression Behavior Behavioral Symptoms HIV Mental Disorders Personal Satisfaction Posttraumatic Stress Disorder Psychological Well-Being Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Trauma and Stressor Related Disorders

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Family AIDS Care Education and Services

Kisumu, Nyanza, Kenya

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

interpersonal psychotherapy

Behavioral

Interpersonal psychotherapy is an evidence based, structured, brief psychotherapy which improves relationships in order to improve mood and reduce anxiety

Treatment as Usual

Behavioral

Clinic psychosocial treatment as usual

Primary outcomes

  1. Depression, PTSD

    Time frame: Change from 0-12 weeks, 12-24 weeks and 24-36 weeks

    structured clinical interview: Composite International Diagnostic Interview (CIDI)

Secondary outcomes

  1. ARV adherence

    Time frame: Change from 0-12 weeks, 12-24 weeks and 24-36 weeks

    Visual Analog Scale self-report

  2. HIV viral load

    Time frame: 12 weeks, 24 weeks, 36 weeks

    blood draw

Other outcomes

  1. cost analyses

    Time frame: Cost: 12 weeks; benefits (DALYS and productivity): Change from 0-12 weeks, 12-24 weeks and 24-36 weeks

  2. Neurocognitive outcomes

    Time frame: Change from 0-12 weeks, 12-24 weeks and 24-36 weeks

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2019
Study completion
2019
First posted
Dec 19, 2014
Registry last updated
May 1, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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