Integrating HIV and Depression Self-Care to Improve Adherence in Perinatal Women

Yale University

Status: Completed

Conditions: Depression; HIV Infections

Treatments: Behavioral: Attention Control Condition; Behavioral: BEST-maCARE

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03016546

1204010141

R21MH098667-01A1 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

Depression is a common perinatal complication that can have a profound, adverse effect on maternal and child health outcomes. The proposed study will directly address this important, but understudied area by evaluating the feasibility and preliminary effect of an innovative, integrated intervention approach, BEST-maCARE [Better Education, Support, Treatment for maternal Capacity, Adherence, REtention in care]. The multi-component intervention is guided by a model drawn from self-regulation and bioecological systems theory. Proactive counseling personalized to the patient and socio-cultural context is delivered by trained clinic personnel (e.g., counselors) to build problem solving and coping skills and linkages to mental health, HIV treatment and ancillary services. The theory-guided intervention approach has been found effective in improving the health behavior and outcomes (e.g., virologic) of vulnerable, marginalized HIV+ women and men in rural and urban settings in the US (AI38858-ACTG 731; R01NR05108). Although the investigators formative research suggests that it is well suited for the target population, its usefulness in addressing significant gaps in care among perinatal women.

l women with co-morbid conditions in a different socio-cultural, limited resource setting has not been studied.

Full description

The investigators plan to examine the intervention among perinatal women in Bangalore, India in a two phase developmental study. The theory-guided core elements of the intervention will be maintained, but the content and form of the intervention and study procedures that are context/socio-culturally-specific will be adapted in the first phase of the study to enhance relevance and acceptability among the target population. During the second phase of the project, the investigators will train clinic personnel to deliver the intervention and then pilot test the feasibility, acceptability and fidelity of the novel application of the intervention in a randomized controlled trial. After baseline assessment, participants (n=40) will be randomly assigned to BEST-maCARE or a time-matched attention control condition (each delivered over 18 weeks) and outcomes (e.g., depressive symptoms, adherence) evaluated at 6, 12, 18, and 24 weeks post-randomization.

The specific aims are:

1. Conduct elicitation research with patients and providers in Maharashtra, Delhi, Bangalore and Varanasi, India to gain a more nuanced understanding of the sociocultural context and women's perceived assets and barriers to care to guide adaptation of the Best-maCare intervention protocol to optimize socio-cultural relevance, feasibility and acceptability among perinatal women with co-morbid HIV and depression in this setting.
2. Evaluate the feasibility, acceptability, and fidelity of the study procedures and the adapted, standardized Best-maCare and the attention control conditions and explore their preliminary effect in a randomized, controlled pilot study.

2a) The investigators primary thesis is that the adapted Best-maCare will be feasible and acceptable to women living with HIV in Bangalore, India and other stakeholders. In addition, we expect the fidelity of the intervention will be maintained, and, in keeping with the guiding conceptual framework, that there will be a positive relationship between the Best-maCare intervention and women's medication adherence, engagement in care (HIV, mental health, 6-week postpartum health care services) and health outcomes (HIV-1 RNA, depression, 6-weeks postpartum visit).

The focus of this registration is Aim 2.

Enrollment: 40 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Pregnant, HIV+ women, in third trimester (≥28 weeks-delivery)
• Eligible for ART treatment or prophylaxis for the PMTCT, during pregnancy, peripartum and postnatal transmission
• screen positive for depressive symptoms
• Speak English, Hindi or Kannada
• Able to provide informed consent.

Exclusion criteria

• Unable to participate in study visits
• Any condition that, in the opinion of the site investigator, would compromise the candidate's ability to participate.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

BEST-maCARE

Experimental group

Description:

BEST-maCARE intervention will be refined to accommodate our target population using pertinent information attained through interviews conducted with patients representative of the target group and stakeholders from the clinics where the intervention will be pilot tested.

Treatment:

Behavioral: BEST-maCARE

time-matched attention control condition

Active Comparator group

Description:

Participants will be randomly assigned. The control group will receive an intervention that is time and attention equivalent to the experimental condition, though substantively neutral.

Treatment:

Behavioral: Attention Control Condition