A Multidisciplinary "Integrated Management Team to Improve Maternal-Child Outcomes (IMPROVE)" Intervention to Improve Maternal and Child Outcomes in Lesotho

NCT04598958 | Completed

• 1 other identifier: EG0142
• Study Type: interventional
• Target: 1,004
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study aims to improve maternal and child health (MCH) outcomes by implementing and evaluating a multidisciplinary "Integrated Management Team to Improve Maternal-Child Outcomes (IMPROVE)" intervention to increase MCH, antiretroviral therapy (ART), and HIV services uptake and retention in Lesotho. The proposed intervention will focus efforts to improve the effectiveness of existing village health workers (VHW) and HIV support organizations (Lesotho Network of AIDS Service Organizations \[LENASO\] and Mothers2Mothers \[M2M\]) based at the facility and coordination between the facility and community. The IMPROVE intervention includes: (1) Multidisciplinary integrated management teams to coordinate patient-focused and outcome-oriented PMTCT and MCH services; (2) Enhanced Positive Health, Dignity, and Prevention (PHDP)-focused counseling and skills-building training and job aids; and (3) Increased early community-based counseling and support for first (antenatal care clinic) ANC attendees with particular attention to HIV-positive women to minimize loss to follow-up. The study will be a cluster randomized design with facilities randomized to receive the IMPROVE intervention or routine services offering the national standard of care. A cohort of HIV-positive and HIV-negative pregnant women will be enrolled and prospectively followed every three months through pregnancy and until the participant's child reaches 24 months of age. The primary HIV objectives will be to evaluate the effect of the intervention on retention in HIV care, viral suppression, adherence to ART in HIV-positive women, and HIV retesting in HIV-negative women. The investigators will also assess the effect of the IMPROVE intervention on general MCH indices including antenatal care (ANC) attendance, facility delivery, family planning, and immunization coverage. Secondary objectives include evaluation of adherence self-efficacy (HIV positive) or prevention self-efficacy (HIV negative), depression and stigma as well as disclosure, knowledge of partner status, and identification of discordant couples in intervention versus control facilities. Analysis of the cost-effectiveness of the IMPROVE intervention will also be conducted. In addition, qualitative interviews and focus group discussions will be conducted with study women, health care workers (HCW), LENASO, and VHWs to evaluate the feasibility and acceptability of integrating this intervention into routine care.

Conditions

Human Immunodeficiency Virus

Keywords

maternal child health; prevention of mother to child transmission; HIV

Outcome Measures

Primary Outcomes (5)

• Retention

  Proportion of participants retained in care

  at 24 months post partum

• ART Adherence

  Proportion of HIV-positive women on treatment with \>95% adherence based on effective pill count

  at 24 months postpartum

• Viral suppression rate

  Proportion of HIV-positive women with undetectable viral load

  at 24 months postpartum

• HIV retesting rate

  Proportion of HIV-negative women who received additional HIV testing

  at 24 months postpartum

• Targeted MCH health seeking behaviors

  Proportion of women who delivered at a health facility

  At 24 months postpartum

Secondary Outcomes (4)

• General MCH Outcomes

  24 months postpartum

• HIV outcomes

  at 6 weeks of infant age

• Depression

  at enrollment

• Cost-effectiveness of implementing the IMPROVE intervention

  At 24 months postpartum

Study Arms (2)

IMPROVE

EXPERIMENTAL

A cluster of 6 health facilities are to receive the IMPROVE Intervention. The IMPROVE intervention includes: (1) Multidisciplinary integrated management teams to coordinate patient-focused and outcome-oriented PMTCT and MCH services; (2) Enhanced Positive Health, Dignity, and Prevention (PHDP)-focused counseling and skills-building training and job aids; and (3) Increased early community-based counseling and support for first (antenatal care clinic) ANC attendees with particular attention to HIV-positive women to minimize loss to follow-up.

Other: IMPROVE

Standard of care

NO INTERVENTION

A cluster of 6 health facilities receive Standard of Care. Routine health facility services offering the national standard of care for pregnant and breastfeeding women in Lesotho

Interventions

IMPROVE OTHER

Health system interventions that include: (1) Multidisciplinary integrated management teams to coordinate patient-focused and outcome-oriented PMTCT and MCH services; (2) Enhanced Positive Health, Dignity, and Prevention (PHDP)-focused counseling and skills-building training and job aids; and (3) Increased early community-based counseling and support for first (antenatal care clinic) ANC attendees

IMPROVE

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Pregnant woman attending first ANC visit at a study facility . There is no age restriction for study enrollment as young pregnant women in Lesotho are consider emancipated.
• HIV status known at time of enrollment
• Residing in an area around a study facility
• Willing and able to provide informed consent

You may not qualify if:

• Pregnant women attending 2nd or later ANC visits
• Attending care at study facility temporarily
• Significant medical or psychological condition that would preclude active study participation
• Inability to provide informed consent

Sponsors & Collaborators

• Elizabeth Glaser Pediatric AIDS Foundation: lead
• Ministry of Health, Lesotho: collaborator
• United States Agency for International Development (USAID): collaborator
• Avenir Health: collaborator
• Population Council: collaborator
• Johns Hopkins University: collaborator

Related Publications (1)

• Beres LK, Chabela M, Masitha M, Catanzarite Z, Tukei VJ, Mofenson L, Tiam A, Greenberg L, Mokone M, Thabelo R, Nchephe M, Mots'oane T, Guay L, Knowlton AR. An integrated, multidisciplinary management team intervention to improve patient-centeredness, HIV, and maternal-child outcomes in Lesotho: formative research on participatory implementation strategies. BMC Health Serv Res. 2024 Dec 18;24(1):1590. doi: 10.1186/s12913-024-12049-x.

  PMID: 39696296 DERIVED

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

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

Study Officials

• Appolinaire Tiam, MD

  Elizabeth Glaser Pediatric AIDS Foundation

  PRINCIPAL INVESTIGATOR

• Laura A Guay, MD

  Elizabeth Glaser Pediatric AIDS Foundation

  PRINCIPAL INVESTIGATOR

• Lynne Mofenson, MD

  Elizabeth Glaser Pediatric AIDS Foundation

  PRINCIPAL INVESTIGATOR

• Vincent Tukei, MD

  Elizabeth Glaser Pediatric AIDS Foundation

  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

Model Details: This is a cluster randomized design. Two clusters of health facilities were randomized to receive either the intervention or standard of care. There are 6 facilities in each cluster. Individual participants are treated based on the cluster they fall into

Study Record Dates

• First Submitted: October 5, 2020
• First Posted: October 22, 2020
• Study Start: July 27, 2016
• Primary Completion: July 31, 2019
• Study Completion: September 30, 2020
• Last Updated: October 22, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share