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

NCT03016546 | Completed DMC

• 2 other identifiers: 1204010141R21MH098667-01A1
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV Infections; Depression

Keywords

Pregnancy

Outcome Measures

Primary Outcomes (4)

• Program feasibility and acceptability composite

  We will use protocol specific tools to measure feasibility, user acceptability, fidelity and safety of the intervention and study protocol. The assessment will include: 1) The ratio of eligible study participants to those enrolled; 2) Number of scheduled study visits completed; 3) Attrition between baseline and follow-up; 4) Reason for premature drop-out; 5) Number of phone calls that were made on schedule; 6) Level of participation in intervention sessions including the total number sessions, number of sessions completed without break offs, number of break offs, length (minutes) of sessions; 7) Congruence of topic/content discussed on calls with protocol; 8) Patient and study nurse satisfaction with intervention content, mode of delivery, and protocol; 9) Adverse events.

  6 weeks post-delivery

• the participant's medication adherence (self-report-ACTG Adherence Questionnaire)

  6 weeks post-delivery

• viral load (serum HIV-1 RNA)

  6 weeks post-delivery

• depression (self-report-EPDS -Edinburgh Postnatal Depression Scale)

  This scale is a 10-item self-report questionnaire with a possible score range of 0 to 30. Items 1, 2, and 4 are scored 0, 1, 2 or 3 with the top box scored as 0 and the bottom box scored as 3. Items 3 and 5-10 are reverse scored, with the top box scored as 3 and the bottom box scored as 0. The cut-off point for detecting depression was identified as a score of \>10. Cases with scores ≥14 were considered to be severely depressed.

  6 weeks post-delivery

Study Arms (2)

BEST-maCARE

EXPERIMENTAL

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.

Behavioral: BEST-maCARE

time-matched attention control condition

ACTIVE COMPARATOR

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.

Behavioral: Attention Control Condition

Interventions

BEST-maCARE BEHAVIORAL

Features of the integrated BEST-maCARE intervention approach include: Integration of depression screening and linkages to HIV and mental health treatment in the context of perinatal care; A trained, clinic-based nurse (study nurse) plays a mediating role between the health system and its beneficiaries; scheduling of appointments; and, accompanying the patient as needed to initial appointments if desired, and, follow up. Low cost, mobile phone technology is used for frequent one:to:one patient contact with a health care provider (the study nurse) to facilitate continuity of care (for mental health, HIV and pregnancy across the continuum of care from prenatal through postpartum) and promotion of self-care (adherence) and retention in care with a theory-guided, empirically-supported, standardized counseling intervention that is delivered proactively by the study nurse over 18 weeks.

BEST-maCARE

Attention Control Condition BEHAVIORAL

The control group will receive an intervention that is time and attention equivalent to the experimental condition. The attention effect that is likely with provision of a mobile phone in the experimental condition will be controlled by providing mobile phone to the control group participants and, they will receive time matched calls from the study nurse with content of the calls focused on infant and maternal nutritional health education per Indian National Guidelines. The phone will be used for delivery of the interventions and may also be used by study staff for purposes of establishing contact or to collect survey interview data if necessary. Time, date, and content of all phone contacts will be documented by the nurse and evaluated in the analysis.

time-matched attention control condition

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Yale University: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

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

New Delhi, 110002, India

Location

MeSH Terms

Conditions

HIV Infections; Depression

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Behavioral Symptoms; Behavior

Study Officials

• Nancy Reynolds

  Yale University School of Nursing

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 6, 2017
• First Posted: January 10, 2017
• Study Start: December 1, 2016
• Primary Completion: July 31, 2018
• Study Completion: July 31, 2018
• Last Updated: August 17, 2020

Record last verified: 2010-08

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)