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

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

Study Overview

• Status: Completed
• Conditions: Depression; HIV; Posttraumatic Stress Disorder
• Intervention / Treatment: Behavioral: treatment as usual; Behavioral: interpersonal psychotherapy

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 300
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Kenya
  • Nyanza
    • Kisumu, Nyanza, Kenya
      • Family AIDS Care Education and Services

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Time Frame
cost analyses	Cost: 12 weeks; benefits (DALYS and productivity): Change from 0-12 weeks, 12-24 weeks and 24-36 weeks
Neurocognitive outcomes	Change from 0-12 weeks, 12-24 weeks and 24-36 weeks

Collaborators and Investigators

• Sponsor: University of California, San Francisco
• Collaborators: National Institute of Mental Health (NIMH)

Publications and helpful links

General Publications

• Meffert SM, Neylan TC, McCulloch CE, Blum K, Cohen CR, Bukusi EA, Verdeli H, Markowitz JC, Kahn JG, Bukusi D, Thirumurthy H, Rota G, Rota R, Oketch G, Opiyo E, Ongeri L. Interpersonal psychotherapy delivered by nonspecialists for depression and posttraumatic stress disorder among Kenyan HIV-positive women affected by gender-based violence: Randomized controlled trial. PLoS Med. 2021 Jan 11;18(1):e1003468. doi: 10.1371/journal.pmed.1003468. eCollection 2021 Jan.
• Opiyo E, Ongeri L, Rota G, Verdeli H, Neylan T, Meffert S. Collaborative Interpersonal Psychotherapy for HIV-Positive Women in Kenya: A Case Study From the Mental Health, HIV and Domestic Violence (MIND) Study. J Clin Psychol. 2016 Aug;72(8):779-83. doi: 10.1002/jclp.22359. Epub 2016 Jul 27.
• Onu C, Ongeri L, Bukusi E, Cohen CR, Neylan TC, Oyaro P, Rota G, Otewa F, Delucchi KL, Meffert SM. Interpersonal psychotherapy for depression and posttraumatic stress disorder among HIV-positive women in Kisumu, Kenya: study protocol for a randomized controlled trial. Trials. 2016 Feb 3;17:64. doi: 10.1186/s13063-016-1187-6. Erratum In: Trials. 2016;17(1):151.

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2015
• Primary Completion (Actual): January 31, 2019
• Study Completion (Actual): January 31, 2019

Study Registration Dates

• First Submitted: September 9, 2014
• First Submitted That Met QC Criteria: December 15, 2014
• First Posted (Estimate): December 19, 2014

Study Record Updates

• Last Update Posted (Actual): May 1, 2019
• Last Update Submitted That Met QC Criteria: April 29, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Keywords: HIV; mental health; women; africa; gender based violence; interpersonal psychotherapy; kenya; global mental health; HIV treatment adherence
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Trauma and Stressor Related Disorders; Stress Disorders, Traumatic; Depression; Depressive Disorder; Stress Disorders, Post-Traumatic
• Other Study ID Numbers: 1K23MH098767-01A1 (U.S. NIH Grant/Contract); K23MH098767 (U.S. NIH Grant/Contract)