Clinical trial NCT03069417: Support for Perinatal Adherence and Depression
Official title: Project INSPireD: Integrating Nuanced Support for Perinatal Adherence and Depression
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Human Immunodeficiency Virus
Depression
Keywords: HIV
Medication adherence
PMTCT
Depression
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: Match Research
name: National Institute of Mental Health (NIMH)
First posted: 2017-03-03
Enrollment: 23
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The main aim was to conduct a pilot field test of a group-based depression and adherence counseling intervention with HIV-infected women in the perinatal period. Participants were HIV-infected women living in KwaZulu-Natal, South Africa.

Detailed description: The main aim of this study was to conduct a pilot field test of a group-based counseling intervention with HIV-infected women in the perinatal period as delivered by a lay counselor. The primary goal of the intervention was to reduce symptoms of perinatal depression and increase adherence to antiretroviral therapy among HIV-infected women during pregnancy and the postpartum period.

Eligibility criteria: Inclusion Criteria:

* Currently pregnant
* HIV-infected and diagnosed with HIV during the index pregnancy
* Meet criteria for a major depressive episode
* Currently on antiretroviral therapy
* Receiving antenatal care at PMMH Gateway clinic
* Primary language English or isiZulu
* Access to a phone and willing to give researchers permission to reach them via phone
* Resident of Umlazi

Exclusion Criteria:

* Unable or unwilling to provide informed consent
* Active untreated, major mental illness (untreated psychosis, bipolar disorder, dementia, or active suicidality) that would interfere with study participation
* Less than 18 years of age

Primary outcomes:
measure: Adherence to Antiretroviral Therapy Per Self-Report
timeFrame: Baseline, Post-Treatment (8-10 weeks), 3-Month Follow-Up (up to 6 months post-baseline)
measure: Adherence to Antiretroviral Therapy Per MEMS Caps
timeFrame: Baseline, Post-Treatment (8-10 weeks), 3-Month Follow-Up (up to 6 months post-baseline)
measure: Level of Depressive Symptoms Per Edinburgh Postnatal Depression Scale (EPDS)
timeFrame: Baseline, Post-Treatment (8-10 weeks), 3-Month Follow-Up (up to 6 months post-baseline)
measure: Number of Participants With Depressive Symptoms Per MINI - Meeting Criteria for MDD
timeFrame: Baseline, Post-Treatment (8-10 weeks), 3-Month Follow-Up (up to 6 months post-baseline)
Secondary outcomes:
measure: Level of Stigma Per HIV/AIDS Stigma Instrument (HASI-P)
timeFrame: Baseline, Post-Treatment (8-10 weeks), 3-Month Follow-Up (up to 6 months post-baseline)
measure: Level of Social Support Per Duke-UNC Functional Social Support Questionnaire
timeFrame: Baseline, Post-Treatment (8-10 weeks), 3-Month Follow-Up (up to 6 months post-baseline)
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Durban
country: South Africa
facility: MatCH Research
Study officials:
affiliation: Massachusetts General Hospital
name: Christina Psaros, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lu M, Safren SA, Skolnik PR, Rogers WH, Coady W, Hardy H, Wilson IB. Optimal recall period and response task for self-reported HIV medication adherence. AIDS Behav. 2008 Jan;12(1):86-94. doi: 10.1007/s10461-007-9261-4. Epub 2007 Jun 19.
citation: Psaros C, Stanton AM, Raggio GA, Mosery N, Goodman GR, Briggs ES, Williams M, Bangsberg D, Smit J, Safren SA. Optimizing PMTCT Adherence by Treating Depression in Perinatal Women with HIV in South Africa: A Pilot Randomized Controlled Trial. Int J Behav Med. 2023 Feb;30(1):62-76. doi: 10.1007/s12529-022-10071-z. Epub 2022 Mar 8.
citation: Choi KW, Smit JA, Coleman JN, Mosery N, Bangsberg DR, Safren SA, Psaros C. Mapping a Syndemic of Psychosocial Risks During Pregnancy Using Network Analysis. Int J Behav Med. 2019 Apr;26(2):207-216. doi: 10.1007/s12529-019-09774-7.