Randomized Controlled Trial of Interpersonal Psychotherapy for Depression and PTSD Among HIV+ Women in Kenya
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|ClinicalTrials.gov Identifier: NCT02320799|
Recruitment Status : Active, not recruiting
First Posted : December 19, 2014
Last Update Posted : November 28, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Depression Posttraumatic Stress Disorder HIV||Behavioral: interpersonal psychotherapy Behavioral: treatment as usual||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||300 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Randomized Controlled Trial of Interpersonal Psychotherapy for Depression and PTSD Among HIV-infected Women Exposed to Gender Based Violence in Kenya|
|Actual Study Start Date :||September 2015|
|Estimated Primary Completion Date :||January 31, 2019|
|Estimated Study Completion Date :||January 31, 2019|
Active Comparator: treatment as usual
Usual Clinic psychosocial treatment
Behavioral: treatment as usual
Clinic psychosocial treatment as usual
Experimental: interpersonal psychotherapy
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
Interpersonal psychotherapy is an evidence based, structured, brief psychotherapy which improves relationships in order to improve mood and reduce anxiety
- Depression, PTSD [ Time Frame: Change from 0-12 weeks, 12-24 weeks and 24-36 weeks ]structured clinical interview: Composite International Diagnostic Interview (CIDI)
- ARV adherence [ Time Frame: Change from 0-12 weeks, 12-24 weeks and 24-36 weeks ]Visual Analog Scale self-report
- HIV viral load [ Time Frame: 12 weeks, 24 weeks, 36 weeks ]blood draw
- cost analyses [ Time Frame: Cost: 12 weeks; benefits (DALYS and productivity): Change from 0-12 weeks, 12-24 weeks and 24-36 weeks ]
- Neurocognitive outcomes [ Time Frame: Change from 0-12 weeks, 12-24 weeks and 24-36 weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02320799
|Family AIDS Care Education and Services|
|Kisumu, Nyanza, Kenya|
|Principal Investigator:||Susan M Meffert, MD, MPH||University of California, San Francisco|