Human Immunodeficiency VirusNCT02403583
Jamii Bora: A Home-Based Couples Intervention
A study testing Intervention- Home Visits in people with Human Immunodeficiency Virus, run by University of Alabama at Birmingham at 5 sites in Kenya.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Human Immunodeficiency Virus
- What is being tested?
- Intervention- Home Visits
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 233 participants
- Where
- 5 sitesKenya
- Study dates
- 1 Aug 2014to 31 Mar 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- (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.
Who cannot join
- (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
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Kenya5 sites
Macalder District Hospital
Migori, Migori County
Oyani Health Center
Migori, Migori County
Wath Onger
Othoch Rakuom, Migori County
Rongo District Hospital
Rongo, Migori County
God Jope Dispensary
Suna, Mirgori
About this study
Official title: Jamii Bora: A Home-based Couples Intervention
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.
Read the detailed description
Despite the potential for anti-retroviral therapy (ART) to ensure maternal health and reduce vertical HIV transmission to as low as 1%, HIV-related maternal deaths and HIV infection among infants remain unacceptably high across sub-Saharan Africa. Prevention of mother-to-child transmission (PMTCT) requires a complex series of interventions throughout pregnancy and after birth, and only an estimated 15-30% of eligible women complete this "PMTCT cascade". Drop-offs can occur in the PMTCT cascade if women refuse HIV testing, do not disclose their HIV status, or avoid essential health services because they fear negative consequences for their relationship with their male partner. Engaging both partners of a couple during pregnancy has the potential to enhance health decisions, increase healthcare utilization, and ultimately improve maternal, paternal, and infant health. The goal of this study is to develop and pilot a home-based couples intervention that includes safe HIV testing and disclosure for couples, alongside information and counseling for family health during the perinatal period. The investigators will adapt existing evidence-based Couples HIV Counseling and Testing (CHCT) protocols for the special needs of pregnant women and their male partners, and train pairs of lay health workers (one female and one male) to deliver this service as part of home visits in rural Kenya. As men rarely attend antenatal clinics in Kenya, a home-based strategy can reach the couple in a safe and convenient space and give them unprecedented access to family health information, CHCT services, and linkage to care. This intervention, based on an interdependence model of communal coping and behavior change, is expected to help couples to communicate, plan, and take action around HIV and family health. Building on our team's preliminary studies in this rural Kenyan setting, the investigators collected further formative data and translated our findings into a viable intervention model with input from local stakeholders. The investigators will then conduct a pilot study of the home-based couples intervention, in which the investigators will randomize pregnant women at two antenatal clinics to the intervention or standard care arms of the study, and follow them and their male partners until three months after the expected delivery date of the baby. The investigators will preliminarily assess the effects of the intervention on uptake of CHCT by couples, repeat HIV testing during pregnancy for HIV-negative women, and utilization of PMTCT and HIV services for HIV-positive women and men. The investigators will also explore the roles of potential mediators for these effects suggested by our interdependence conceptual framework (such as measures of couple relationship dynamics). Results from this study will provide evidence of the preliminary impact, acceptability, and feasibility of the intervention and the study methods that will allow our team to develop a larger-scale efficacy trial. Engaging pregnant couples in family health and PMTCT is an essential step towards reducing HIV-related maternal mortality and eliminating new HIV infections among children in sub-Saharan Africa.
- Conditions
- Human Immunodeficiency Virus
- Being tested
- Intervention- Home Visits
- Keywords
- HIV Transmission, Prevention of Mother to Child Transmission, Serodiscordancy, Home-based testing, Home-based counseling, Linkage to care, Couples HIV Testing and Counseling, Acceptance of repeat HIV testing during pregnancy, Retention in care
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention- Home VisitsBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention- Home visits | Other | Participants randomized to intervention arm receive 3 home visits conducted by one female and one male lay health worker. Receives: Behavioral: Intervention- Home Visits |
| Standard Care | No intervention | Participants 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 3 months after the expected due date of the baby
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2015 (estimated)
- Study start1 Aug 2014
- Primary completion31 Mar 2017
- Study completion31 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Human Immunodeficiency VirusStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 233 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- Kenya Medical Research Institute, University of California, San Francisco, National Institute of Mental Health (NIMH), University of Michigan
- Responsible party
- Principal investigator, Janet M. Turan, PhD, University of Alabama at Birmingham
- Investigators
- Janet M Turan, PhD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02403583
- Sponsor's protocol ID
- X140304009
- Other IDs
- 1R34MH102103-01A1
- Status last verified
- Apr 2017
- First submitted
- 24 Feb 2015
- Last updated
- 6 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 29620927
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Jamii Bora: A Home-based Couples Intervention
- ClinicalTrials.gov ID
- NCT02403583
- Acronym / sponsor ID
- X140304009
- Conditions
- Human Immunodeficiency Virus
- Keywords
- HIV Transmission, Prevention of Mother to Child Transmission, Serodiscordancy, Home-based testing, Home-based counseling, Linkage to care, Couples HIV Testing and Counseling, Acceptance of repeat HIV testing during pregnancy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 233 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Collaborators
- Kenya Medical Research Institute, University of California, San Francisco, National Institute of Mental Health (NIMH), University of Michigan
- Study start
- 1 Aug 2014 (actual)
- Primary completion
- 31 Mar 2017 (actual)
- Study completion
- 31 Mar 2017 (actual)
- First posted
- 31 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Despite the potential for anti-retroviral therapy (ART) to ensure maternal health and reduce vertical HIV transmission to as low as 1%, HIV-related maternal deaths and HIV infection among infants remain unacceptably high across sub-Saharan Africa. Prevention of mother-to-child transmission (PMTCT) requires a complex series of interventions throughout pregnancy and after birth, and only an estimated 15-30% of eligible women complete this "PMTCT cascade". Drop-offs can occur in the PMTCT cascade if women refuse HIV testing, do not disclose their HIV status, or avoid essential health services because they fear negative consequences for their relationship with their male partner. Engaging both partners of a couple during pregnancy has the potential to enhance health decisions, increase healthcare utilization, and ultimately improve maternal, paternal, and infant health. The goal of this study is to develop and pilot a home-based couples intervention that includes safe HIV testing and disclosure for couples, alongside information and counseling for family health during the perinatal period. The investigators will adapt existing evidence-based Couples HIV Counseling and Testing (CHCT) protocols for the special needs of pregnant women and their male partners, and train pairs of lay health workers (one female and one male) to deliver this service as part of home visits in rural Kenya. As men rarely attend antenatal clinics in Kenya, a home-based strategy can reach the couple in a safe and convenient space and give them unprecedented access to family health information, CHCT services, and linkage to care. This intervention, based on an interdependence model of communal coping and behavior change, is expected to help couples to communicate, plan, and take action around HIV and family health. Building on our team's preliminary studies in this rural Kenyan setting, the investigators collected further formative data and translated our findings into a viable intervention model with input from local stakeholders. The investigators will then conduct a pilot study of the home-based couples intervention, in which the investigators will randomize pregnant women at two antenatal clinics to the intervention or standard care arms of the study, and follow them and their male partners until three months after the expected delivery date of the baby. The investigators will preliminarily assess the effects of the intervention on uptake of CHCT by couples, repeat HIV testing during pregnancy for HIV-negative women, and utilization of PMTCT and HIV services for HIV-positive women and men. The investigators will also explore the roles of potential mediators for these effects suggested by our interdependence conceptual framework (such as measures of couple relationship dynamics). Results from this study will provide evidence of the preliminary impact, acceptability, and feasibility of the intervention and the study methods that will allow our team to develop a larger-scale efficacy trial. Engaging pregnant couples in family health and PMTCT is an essential step towards reducing HIV-related maternal mortality and eliminating new HIV infections among children in sub-Saharan Africa.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention- Home visits | Other | Behavioral: Intervention- Home VisitsParticipants randomized to intervention arm receive 3 home visits conducted by one female and one male lay health worker. |
| Standard Care | No intervention | –Participants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- (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.
Key exclusion criteria (1 listed)
- (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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intervention- Home VisitsIf 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. | Behavioural | Intervention- Home visits |
Primary outcome
Utilization of maternal and child health (MCH) services (outcome for all couples in the study)
Time frame: 3 months after the expected due date of the baby
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.
Use of PMTCT interventions (for HIV+ women only)
Time frame: 3 months after the expected due date of the baby
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2017.
- Derived from this study: PubMed 29620927Turan 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janet M Turan, PhD principal investigator
University of Alabama at Birmingham
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention- Home Visits in people with Human Immunodeficiency Virus, run by University of Alabama at Birmingham at 5 sites in Kenya.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Kenya. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Utilization of maternal and child health (MCH) services (outcome for all couples in the study) (time frame: 3 months after the expected due date of the baby). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02403583, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2017.