Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03698981 |
| Other study ID # |
TW011084-01 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
March 15, 2019 |
| Est. completion date |
January 14, 2021 |
Study information
| Verified date |
March 2021 |
| Source |
New York University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The goal of this proposal is to use a theoretically grounded approach to culturally-tailor a
stigma intervention among just identified, pregnant HIV+ women in Botswana. This project will
use empirically tested stigma interventions that have shown efficacy for serious mental
illness and to adapt these to HIV. Additionally, a novel component of this intervention is
the utilization of peers (i.e., mothers with HIV), which has been shown to be an effective
stigma reduction agent for other conditions but has not yet been widely used with HIV.
The investigators propose to leverage this middle-income context to conduct a Randomized
Controlled Trial (RCT) with HIV+ women (n=100 intervention group, n=100 control group). The
investigators examine the stigma intervention for outcomes among mothers (including adherence
to Antiretroviral therapy [ART] and antenatal treatment), and conduct exploratory birth
outcomes among infants (e.g., birth weight, time of delivery) as well. Capacity building
activities to transfer stigma intervention knowledge will occur throughout the project to
enable investigators in Botswana to independently develop stigma interventions, thus serving
as a model for other African countries. Finally, this pilot intervention will provide
valuable data for future intervention trials to reduce stigma and improve ART adherence.
Description:
To be completed by University of Botswana Research team:
The investigators will sample from the Dept. of Obstetrics and Gynecology (OB/GYN) at
Princess Marina Hospital IDCC. Newly-diagnosed pregnant HIV+ women are referred to OB care at
Ministry of Health (MOH) antenatal clinics and receive HIV care at the IDCC for continued
ART. To account for expected drop out (~10%), ~220 participants will be recruited. All
participants will be randomized to receive MME (the HIV-stigma intervention) or TAU
(treatment as usual) from week 28-36 of their pregnancy. The investigators will initiate MME
in the antenatal period because the cultural practice of botsetsi (below) could impede
implementation post-partum. All participants will have PMTCT by initiation of ART before week
32. Adherence to ART, antenatal and PP care, and viral load testing will be tracked from week
28 of pregnancy to 16 weeks PP (~week 56 for full-term babies).
Procedures. To account for expected drop out (~10%), ~220 participants will be recruited,
resulting in MME and TAU groups of ~100 with complete data at week 56. For the MME
(intervention) arm, the investigators will enroll 9-10 women per group on a rolling basis to
comprise ~12 intervention groups total; ~1 MME group will be initiated per month.
Intervention & Assessment Procedures. One advantage of our study is that, whenever possible,
the investigators augment self-report measures with objective measures from medical records
(i.e., for infants, birth-weights, APGAR scores at birth; for antenatal treatment, an
Antenatal/delivery record tracking antenatal visits that is filled out by doctors; for ART,
CD4 count and Viral load data from the integrated patient management system). Fidelity
assessments for each session will be evaluated by Ho-Foster. Control Description: Control
condition participants will receive TAU, including using free ART and antenatal services as
they wish. Control condition participants are assessed on all 'Primary outcomes' at the same
time points as the intervention group.
Follow-up Assessment (Months 18-22): Mothers' Postpartum (PP) adherence (56 weeks) serves as
a key outcome. The investigators examine a set of exploratory, infant birth outcomes that may
result from improved antenatal care and ART adherence. The investigators use an "Under 5
(years old) card" that is filled out by a doctor to track infant's developmental outcomes
which is carried by the mother. Child outcomes include: APGAR score, preterm delivery,
mortality (at <16 weeks), birthweight, vaccination record, and mother-to-child-transmission
of HIV (MTCT). The investigators will call each participant at 4 months' time and ask to meet
in person to review their "Under 5 card" to record infant outcomes at both: a) time of birth;
b) 16 weeks PP.
