N/A
N=23
Support for Perinatal Adherence and Depression
Human Immunodeficiency Virus · Depression
Bottom Line
View on ClinicalTrials.gov: NCT03069417 ↗Enrolled (actual)
23
Serious AEs
0.0%
Results posted
Dec 2021
Primary outcome: Primary: Adherence to Antiretroviral Therapy Per Self-Report — 85.3; 79.0; 92.8; 77.8 percentage of self-reported adherence — p=0.11
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Integrating Nuanced Support for Perinatal adherence and Depression (Behavioral)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Massachusetts General Hospital
- Primary completion
- Mar 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Adherence to Antiretroviral Therapy Per Self-Report |
85.3; 79.0; 92.8; 77.8; 88.7; 89.2 | 0.11 |
| PRIMARY Adherence to Antiretroviral Therapy Per MEMS Caps |
99.4; 92.9; 98.6; 100.0; 92.8; 85.7 | < 0.05 sig |
| PRIMARY Level of Depressive Symptoms Per Edinburgh Postnatal Depression Scale (EPDS) |
20.8; 20.3; 1.2; 11.8; 2.1; 6.5 | < 0.005 sig |
| PRIMARY Number of Participants With Depressive Symptoms Per MINI - Meeting Criteria for MDD |
12; 7; 0; 2; 0; 1 | — |
| SECONDARY Level of Stigma Per HIV/AIDS Stigma Instrument (HASI-P) |
14.3; 24.3; 6.3; 12.8; 2.5; 12.5 | < 0.05 sig |
| SECONDARY Level of Social Support Per Duke-UNC Functional Social Support Questionnaire |
33.9; 27.7; 35.3; 28.0; 36.4; 36.5 | < 0.05 sig |
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.
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
Data sourced from ClinicalTrials.gov (NCT03069417). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.