Clinical trial NCT03016546: Integrating HIV and Depression Self-Care to Improve Adherence in Perinatal Women
Official title: Integrating HIV and Depression Self-Care to Improve Adherence in Perinatal Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV Infections
Depression
Keywords: Pregnancy
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2017-01-10
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Program feasibility and acceptability composite
timeFrame: 6 weeks post-delivery
measure: the participant's medication adherence (self-report-ACTG Adherence Questionnaire)
timeFrame: 6 weeks post-delivery
measure: viral load (serum HIV-1 RNA)
timeFrame: 6 weeks post-delivery
measure: depression (self-report-EPDS -Edinburgh Postnatal Depression Scale)
timeFrame: 6 weeks post-delivery
Secondary outcomes:
Other outcomes:
Locations:
city: New Delhi
country: India
facility: Maulana Azad Medical College and Associated Lok Nayak Hospital, G.B. Pant Institute of Postgraduate Medical Education and Research Hospital and Guru Nanak Eye Center
Study officials:
affiliation: Yale University School of Nursing
name: Nancy Reynolds
role: PRINCIPAL_INVESTIGATOR
References: