Healthy Options: Group Psychotherapy for HIV-positive Depressed Perinatal Women.

NCT02039973 | Completed DMC

• 1 other identifier: 1R01MH100338-01
• Study Type: interventional
• Target: 742
• Locations: 1 country
• Sites: 1

Brief Summary

Although there is a significant burden of depression among HIV-positive women in Tanzania, there is a critical gap between the needs of this population and the integration of mental health and PMTCT-plus services. The long-term intent of the research is to bridge this gap with the overall goal to examine the potential for successful integration of enhanced mental health care and brief group interventions among HIV-positive women receiving PMTCT-plus services and to evaluate a combination of evidence-based approaches for treatment of depression in this vulnerable population in Tanzania.

Conditions

Depression

Keywords

HIV; AIDS; Tanzania; depression; perinatal; psychotherapy; task-sharing; problem-solving

Outcome Measures

Primary Outcomes (1)

• Depressive disorder and suicidality

  Using a cut-off score based on the validation study, participants will be classified as having depressive and or suicidality or not. The trial aims to reduce rates of depression and suicidality among participants.

  Q3 2016 after an average of 1.5 years of follow-up

Secondary Outcomes (9)

• Social support

  Q3 2016 after an average of 1.5 years of follow-up

• Self-Efficacy

  Q3 2016 after an average of 1.5 years of follow-up

• HIV-related stigma

  Q3 2016 after an average of 1.5 years of follow-up

• Intimate partner violence

  Q3 2016 after an average of 1.5 years of follow-up

• Infant birthwight

  At time of birth

Study Arms (2)

Task-sharing approach to group therapy

EXPERIMENTAL

The intervention will consist of problem-solving therapy as well as cognitive behavioral components. Core problem-solving therapy components will involve lay CBHW facilitated discussions to explore symptoms of depression and how problems are related to depression. Core cognitive behavioral components will include lay CBHW facilitated discussions to explain the purpose of the sessions, as well as effect a number of behavioral changes in participants.

Behavioral: Task-sharing approach to group therapy

Enhanced standard of care

ACTIVE COMPARATOR

The control condition will promote an enhanced standard of care. Clinicians and nurses at MCH clinics included in the study will receive a structured one day re-orientation training consistent with the World Health Organization (WHO) mh-GAP guidelines for assessment as well as basic psychosocial and drug treatment of moderate to severe depression in primary care settings. The training will be consistent with the standard of care for mental health among HIV-positive populations as outlined in Tanzanian health policy. In addition, clinical staff will be trained to encourage women to invite their male partners to accompany them at clinic visits, where psycho-education on perinatal depression for couples will be offered for those opting to participate.

Behavioral: Enhanced standard of care

Interventions

Task-sharing approach to group therapy BEHAVIORAL

Participants will also identify, select and clarify common concerns/problems; provide orientation to steps in problem-solving; break down identified problems into manageable pieces; choose pieces of problem to address in facilitated discussion of problem solving for implementing solutions; support the sharing of feedback of strategies used in problem-solving and maintaining pleasurable activities. Additionally, the intervention to aim to effect behavior by: explaining the links between problems, negative thoughts, choices made on a day-to-day basis, behaviors, and mood (symptoms of depression); facilitate sharing of practical skills to tackle problems, to change mood-related thoughts, choices and/or behaviors; offer and provide feedback on homework assignments to encourage practice of skills; and help participants attribute reported improvements to the use of new skills during feedback sessions.

Task-sharing approach to group therapy

Enhanced standard of care BEHAVIORAL

Enhanced standard of care

Eligibility Criteria

• Age: 18 Years - 49 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• pregnant women who access PMTCT-plus services at MCH clinics in Dar es Salaam
• HIV-positive serostatus
• screen positive for depression
• less than 28 weeks of gestation
• confirm they will attend postnatal services at the maternal and child health service they enrolled in for antenatal care for at least two years after they give birth

You may not qualify if:

• any woman less than 18 years of age
• HIV-negative
• screened negative for depression
• screened positive for depression and assessed to be of high suicide risk requiring immediate emergency referral for care
• not able to continue to receive care at the MCH clinic where they were initially enrolled for at least two years after giving birth

Sponsors & Collaborators

• Harvard Medical School (HMS and HSDM): lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Dar es Salaam City Health Department

Dar es Salaam, Tanzania

Location

Related Publications (2)

• Kaaya S, Siril H, Fawzi MCS, Aloyce Z, Araya R, Kaale A, Kasmani MN, Komba A, Minja A, Mwimba A, Ngakongwa F, Somba M, Sudfeld CR, Larson E. A peer-facilitated psychological group intervention for perinatal women living with HIV and depression in Tanzania-Healthy Options: A cluster-randomized controlled trial. PLoS Med. 2022 Dec 13;19(12):e1004112. doi: 10.1371/journal.pmed.1004112. eCollection 2022 Dec.

  PMID: 36512631 DERIVED

• Smith Fawzi MC, Siril H, Larson E, Aloyce Z, Araya R, Kaale A, Kamala J, Kasmani MN, Komba A, Minja A, Mwimba A, Ngakongwa F, Somba M, Sudfeld CR, Kaaya SF. Healthy Options: study protocol and baseline characteristics for a cluster randomized controlled trial of group psychotherapy for perinatal women living with HIV and depression in Tanzania. BMC Public Health. 2020 Jan 20;20(1):80. doi: 10.1186/s12889-019-7907-6.

  PMID: 31959151 DERIVED

MeSH Terms

Conditions

Depression; Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Mary Kay Smith-Fawzi, ScD

  Harvard Medical School (HMS and HSDM)

  PRINCIPAL INVESTIGATOR

• Sylvia Kaaya, MD, PhD

  Muhimbili University of Health and Allied Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Global Health and Social Medicine

Study Record Dates

• First Submitted: January 1, 2014
• First Posted: January 20, 2014
• Study Start: July 1, 2013
• Primary Completion: December 31, 2017
• Study Completion: December 31, 2017
• Last Updated: February 22, 2018

Record last verified: 2018-02

Locations

TA (1)