Jamii Bora: A Home-Based Couples Intervention
Jamii Bora: A Home-based Couples Intervention
2 other identifiers
interventional
233
1 country
5
Brief Summary
The purpose of the study is to develop and pilot-test a home-based intervention to facilitate sate HIV testing and disclosure within pregnant couples in order to increase use of prevention-of-mother-to-child-transmission (PMTCT) and family health services in Kenya.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Aug 2014
Typical duration for not_applicable
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2014
CompletedFirst Submitted
Initial submission to the registry
February 24, 2015
CompletedFirst Posted
Study publicly available on registry
March 31, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
March 31, 2017
CompletedApril 6, 2017
April 1, 2017
2.7 years
February 24, 2015
April 4, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Utilization of maternal and child health (MCH) services (outcome for all couples in the study)
Composite variable including at having completed least four antenatal care (ANC) visits during pregnancy (Y/N), childbirth with a skilled attendant (Y/N), and postnatal check-ups for woman (Y/N) and infant (Y/N). These are assessed in the follow-up questionnaire completed at three months after the baby's estimated due date.
3 months after the expected due date of the baby
Use of PMTCT interventions (for HIV+ women only)
Composite variable including mothers use of antiretrovirals (ARVs) (Y/N), prophylactic ARVs given to the infant (Y/N), and appropriate infant feeding mode (Y/N). These are assessed in the questionnaire completed at three months after the baby's estimated due date.
3 months after the expected due date of the baby
Other Outcomes (2)
Couple HIV testing (all couples)
3 months after the expected due date of the baby
Antenatal HIV testing (outcome for women who initially tested HIV-negative)
3 months after the expected due date of the baby
Study Arms (2)
Intervention- Home visits
OTHERParticipants randomized to intervention arm receive 3 home visits conducted by one female and one male lay health worker.
Standard Care
NO INTERVENTIONParticipants will receive current standard clinic-based services including the option for women and partners to return to the clinic for male partner HIV testing or CHCT.
Interventions
If a woman has been randomized to the intervention arm, a lay health worker will obtain detailed locator information (including cell phone contacts) and consult with the woman about optimal times for a home visit. The woman will be given a letter for her male partner to inform him about the study and potential upcoming visits, given that our preliminary research revealed that notifying the male partner beforehand is important. As described above, the intervention arm will consist of three home visits conducted by one female and one male lay health worker.
Eligibility Criteria
You may qualify if:
- (a) 18 years of age or older (b) 36 weeks of pregnancy or less (c) has been offered HIV testing at ANC, (d) is currently in a stable relationship (married or cohabiting) with a male partner of duration of at least 6 months (e) is currently living with a male partner who will be in residence at least one night a week at the home during the study period, (f) has not yet participated in couple HIV counseling and testing during this pregnancy (g) has not disclosed current HIV status to male partner (h) does not know with certainty the HIV-positive status of her male partner.
You may not qualify if:
- (a) Currently pregnant (b) Greater than 36 weeks of pregnancy (c) Less than 18 years of age (d) Not currently in a stable relationship of at least 6 months (e) Does not currently live with male partner at least one night a week at the home (f) Has not been offered HIV testing (g) Has received CHCT with current male partner (h) has disclosed current HIV status to male partner (i) Knows with certainty current male partner is HIV-positive
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Alabama at Birminghamlead
- Kenya Medical Research Institutecollaborator
- University of California, San Franciscocollaborator
- National Institute of Mental Health (NIMH)collaborator
- University of Michigancollaborator
Study Sites (5)
Macalder District Hospital
Migori, Migori County, Kenya
Oyani Health Center
Migori, Migori County, Kenya
Wath Onger
Othoch Rakuom, Migori County, Kenya
Rongo District Hospital
Rongo, Migori County, Kenya
God Jope Dispensary
Suna, Mirgori, Kenya
Related Publications (1)
Turan JM, Darbes LA, Musoke PL, Kwena Z, Rogers AJ, Hatcher AM, Anderson JL, Owino G, Helova A, Weke E, Oyaro P, Bukusi EA. Development and Piloting of a Home-Based Couples Intervention During Pregnancy and Postpartum in Southwestern Kenya. AIDS Patient Care STDS. 2018 Mar;32(3):92-103. doi: 10.1089/apc.2017.0285.
PMID: 29620927DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Janet M Turan, PhD
University of Alabama at Birmingham
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
February 24, 2015
First Posted
March 31, 2015
Study Start
August 1, 2014
Primary Completion
March 31, 2017
Study Completion
March 31, 2017
Last Updated
April 6, 2017
Record last verified: 2017-04