Trial record 10 of 37 for:    breastfeeding | NICHD

Home-based Partner Education and Testing (HOPE) Study

This study is enrolling participants by invitation only.
Sponsor:
Collaborators:
Information provided by (Responsible Party):
Carey Farquhar, University of Washington
ClinicalTrials.gov Identifier:
NCT01784783
First received: February 4, 2013
Last updated: October 10, 2013
Last verified: October 2013
  Purpose

The purpose of this study is to investigate the impacts of home-based couple HIV-testing and counseling and male partner education on HIV transmission and other critical maternal and infant health outcomes during pregnancy and the postpartum period. Additionally, the study seeks to assess the cost-effectiveness of this approach.

Involvement of men during the antenatal and postpartum period, including HIV testing of male partners, can have substantial benefits for women and infants. In observational studies, male participation in antenatal care has been associated with increased uptake of prevention of mother-to-child transmission (PMTCT) interventions, and more recently, a study in Kenya found a significant HIV-free survival benefit for children of HIV-infected women whose male partners attended antenatal care where couple HIV testing was offered. In this study only 31% of ~450 men invited for counseling and testing came to clinic, highlighting the challenges faced across sub-Saharan Africa when trying to access male partners of pregnant women.

In areas of high HIV-1 prevalence, high levels of male involvement may be readily achievable because home-based counseling and testing is highly acceptable and the benefits of male participation and HIV testing extend to HIV-uninfected pregnant and postpartum women and infants. Reaching out to men during pregnancy may reduce incident HIV infection and vertical transmission among these women, but efforts to engage men in antenatal care in Western Kenya have thus far achieved limited success. This intervention may achieve gains beyond prevention of maternal and infant HIV-1 acquisition through identification of HIV-infected men who would otherwise not learn their status or delay treatment, and by improving child health through targeted education of male partners. When administered in a home-based setting simple, established interventions such as the promotion of exclusive breastfeeding have been shown to be associated with significant reductions in child mortality. Home-based approaches also lend themselves to integration with targeted interventions such as promotion of HIV testing among male partners of at-risk pregnant women. Furthermore, a successful HIV testing program for male partners of pregnant women has potential to reach a large number of men who may be unaware of their HIV status or who are HIV-infected but not in care, providing linkages to treatment clinics and promoting prevention interventions, such as safe sex and voluntary male circumcision for those who are uninfected.

In this randomized clinical trial up to 600 couples (300 in each treatment arm) will be randomized to standard antenatal care or home-based partner education and HIV testing (HOPE) as part of routine pregnancy services. (Thus, approximately 1,800 subjects are expected for this study, assuming each enrolled woman has an eligible male partner and gives birth to a child.) Women will be enrolled at the antenatal clinic in Kisumu District Hospital, Kisumu, Kenya. Couples in the control group will receive the HOPE Intervention, featuring home-based couple counseling and HIV testing as well as key educational messages concerning HIV prevention behaviors, facility delivery, exclusive breastfeeding, and post-partum family planning. Women in the control arm will be invited to bring their male partners to the antenatal clinic for voluntary clinic testing and counseling. Women will be followed up at clinic visits 6-weeks and 14-weeks postpartum and again with their male partner 6-months post-partum. These follow-up visits will include questionnaires to measure uptake of HIV testing, facility delivery, exclusive breastfeeding and postpartum contraceptive use as well as linkage to HIV care. Cost-effectiveness of the intervention will also be evaluated in order to inform future scale-up.

First, the investigators hypothesize that successful implementation of HOPE will result in benefits to HIV-infected and HIV-uninfected women and their children who will have improved uptake of interventions to improve maternal and child health and reduce vertical and heterosexual HIV transmission. Specifically, the investigators anticipate higher levels of facility delivery, optimal breastfeeding practices, and post-partum contraceptive use, as well as increased uptake of antiretroviral treatment for HIV+ women in the intervention arm, relative to the control arm. Second, the investigators hypothesize that greater than 85% of HIV-1-infected men identified through home-based partner education and testing (HOPE) will access care and treatment services, and, overall, more women in the HOPE arm will know their partners' status at each time point and more partners will be in care and treatment. Third, the investigators predict that uptake of counseling and testing and HIV prevalence among male partners and family members will be high enough to make this approach cost-effective from both payer and societal perspectives.


Condition Intervention
HIV
Behavioral: HOPE Intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: HIV Testing and Educating Male Partners to Improve Maternal and Infant Outcomes: Home-based Partner Education and Testing (HOPE) Study

Resource links provided by NLM:


Further study details as provided by University of Washington:

Primary Outcome Measures:
  • Male self-report of uptake of HIV testing [ Time Frame: 6 months postpartum ] [ Designated as safety issue: Yes ]
    For both arms, male partners will be asked to report whether they received HIV testing during the course of the study. For the intervention arm, records will be kept for home-based testing, while in the control arm, records will be kept for invitation-solicited clinic-based testing.


Secondary Outcome Measures:
  • Female self-report of delivery location [ Time Frame: 6 weeks postpartum ] [ Designated as safety issue: Yes ]
    Female participants will be asked to report where they delivered their baby (e.g. health facility, home, family member's home).

  • Female self-report of delivery assistance [ Time Frame: 6 weeks postpartum ] [ Designated as safety issue: Yes ]
    Female participants will be asked to report who assisted them during delivery (e.g. doctor, nurse, traditional healer, midwife, mother-in-law, etc.)

  • Female self-report of exclusive breastfeeding [ Time Frame: 6 weeks, 14 weeks, and 6 months postpartum ] [ Designated as safety issue: No ]
    Female participants will be asked whether they are currently breastfeeding exclusively.

  • Female self-report of introduction of foods other than breastmilk [ Time Frame: Delivery date to 6 weeks, 14 weeks, and 6 months postpartum ] [ Designated as safety issue: No ]
    Female participants will be asked when milk substitutes (i.e. formula, cow milk) or other foods were introduced to their child.

  • Self report of number of sexual partners (female and male) [ Time Frame: Enrollment and 6 months postpartum ] [ Designated as safety issue: No ]
    Men and women (at enrollment and/or 6 months postpartum) will be asked to report the number of sexual partners they have had during the previous 6 months.

  • Male self-report of male condom use [ Time Frame: Enrollment and 6 months postpartum ] [ Designated as safety issue: Yes ]
    Male participants will be asked to assess their level of condom use during sexual intercourse since during the previous 6 months. Options include 1) always, 2) most occasions, 3) rarely, and 4) never.

  • Female self-report of date of first receptive intercourse after delivery [ Time Frame: 6 weeks, 14 weeks, and 6 months postpartum ] [ Designated as safety issue: Yes ]
    At each follow-up visit, women will be asked whether they have resumed receptive sexual intercourse and, if so, the general time frame that they resumed sex. Upon reporting that they have resumed sexual activity they will no longer be asked this question at remaining interviews.

  • Female report of male condom use [ Time Frame: Enrollment to 6 weeks, 14 weeks, and 6 months postpartum ] [ Designated as safety issue: Yes ]
    Female participants will be asked to assess their partner's level of condom use during sexual intercourse in the previous 6 months (at enrollment and 6 months postpartum) and/or since the last study interview. Options include 1) always, 2) most occasions, 3) rarely, and 4) never.

  • Self-report of condom use during last sexual intercourse (male and female) [ Time Frame: Enrollment, 6 weeks postpartum, 14 weeks postpartum, 6 months ] [ Designated as safety issue: Yes ]
    At each study interview, participants will be asked if they used condom the last time they participated in sexual intercourse.

  • Female self-report of contraceptive use [ Time Frame: 6 weeks, 14 weeks, 6 months postpartum ] [ Designated as safety issue: Yes ]
    After reporting having resumed sexual activity, women will be asked whether they are using contraception. If so, they will be asked what type of contraceptive they have used and how often (for oral medication) or when (for an injectable) they last utilized the contraceptive.

  • Awareness of partner HIV-status [ Time Frame: 6 months postpartum ] [ Designated as safety issue: Yes ]
    Male and female subjects in both the intervention and control arm will be asked to report if they know their partner's status and whether their partner is HIV-negative or HIV-positive.

  • Awareness of partner HIV status (intervention arm) [ Time Frame: Enrollment to 6 months postpartum ] [ Designated as safety issue: Yes ]
    Subjects randomized to the intervention arm will be asked to identify their partner's HIV status during enrollment and at 6 months postpartum. The difference between awareness of partner HIV status before and after the intervention will be evaluated.

  • Male self-report of linkage to HIV care [ Time Frame: 6 months postpartum ] [ Designated as safety issue: Yes ]
    Men who tested HIV-seropositive during the study will be asked to report whether they presented to the Comprehensive Care Clinic.

  • Male self-report of linkage to HIV care for CD4 testing [ Time Frame: 6 months postpartum ] [ Designated as safety issue: No ]
    Men who tested HIV-seropositive during the course of the study will be asked to report whether they received CD4 testing at the Comprehensive Care Clinic.

  • Male self-report of ART initiation [ Time Frame: 6 months postpartum ] [ Designated as safety issue: Yes ]
    HIV-positive male partners will report whether they initiated ART and if not, whether they are eligible.

  • Male self-report of adherence to antiretroviral treatment [ Time Frame: 6 months postpartum ] [ Designated as safety issue: Yes ]
    Men who report initiation of ART will be asked report on their degree of adherence to ART on a visual analogue scale.

  • Female self-report of initiation of prophylaxis [ Time Frame: 6 weeks postpartum ] [ Designated as safety issue: Yes ]
    HIV+ Women will report whether they initiated prophylaxis.

  • Female self-report of Nevirapine treatment for infants [ Time Frame: 6 weeks, 14 weeks, 6 months postpartum ] [ Designated as safety issue: Yes ]
    HIV+ women who reported initiating prophylaxis will be asked whether their infants initiated Nevirapine treatment regimens.

  • Female report of infant adherence to Nevirapine [ Time Frame: 6 weeks, 14 weeks, and 6 months postpartum ] [ Designated as safety issue: Yes ]
    Women who reported infant initiation of Nevirapine will be asked report the degree of the infants adherence to the regimen on a visual analogue scale.

  • Female self-report of initiation of antiretroviral treatment [ Time Frame: Enrollment to 6 weeks, 14 weeks, and 6 months postpartum ] [ Designated as safety issue: Yes ]
    ART-eligible, HIV-positive pregnant subjects will be asked to report whether they initiated ART.

  • Female self-report of adherence to antiretroviral treatment [ Time Frame: Enrollment to 6 weeks, 14 weeks, and 6 months postpartum ] [ Designated as safety issue: Yes ]
    Women who report initiation of ART will be asked report on their degree of adherence to ART on a visual analogue scale.

  • Female self-report of infant mortality [ Time Frame: Delivery to 6 weeks, 14 weeks, and 6 months postpartum ] [ Designated as safety issue: No ]
    At follow-up interviews, women will be asked to report whether the child they delivered was still alive.


Other Outcome Measures:
  • Incremental cost per pregnant woman enrolled [ Time Frame: Enrollment to 6 months postpartum ] [ Designated as safety issue: No ]
  • Incremental cost-effectiveness per infant HIV infection averted [ Time Frame: Enrollment to 6 months postpartum ] [ Designated as safety issue: No ]
  • Incremental cost-effectiveness per maternal HIV infection averted [ Time Frame: Enrollment to 6 months postpartum ] [ Designated as safety issue: No ]
  • Incremental cost-effectiveness HIV-related death and disability adjusted life-year (DALY) averted [ Time Frame: Enrollment to 6 months postpartum ] [ Designated as safety issue: No ]

Estimated Enrollment: 1800
Study Start Date: September 2013
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: HOPE Intervention

Pregnant women and their male partners will receive home-based couple HIV testing and counseling and partner education 1-2 weeks after enrollment. The intervention will include educational messages concerning socio-behavioral, condom-based, and treatment-oriented approaches to prevention of horizontal and vertical HIV transmission, based on the status of each of the partners. The couple will also be educated about the importance of facility delivery, exclusive breastfeeding, family planning, and post-partum contraception.

During the HOPE Intervention, the purpose and design of the study will be explained to male partners. Men will be asked to provide written informed consent for study participation. Provided they consent, men will complete a questionnaire asking for sociodemographic characteristics, medical and sexual history, behavioral data and information on prior HIV testing and counseling.

Behavioral: HOPE Intervention

If the male partner chooses not to complete the study questionnaire, he may decline and participate only in the HOPE intervention component of the study. (This does not preclude the possibility of the female partner continuing to participate in the study.) Investigators anticipate that this will occur and also expect that some women and male partners randomized to the intervention arm will refuse the HOPE intervention when offered. Study staff will attempt to collect data on reasons for refusal to participate and will continue to follow these couples through 6 months postpartum to collect maternal and infant outcome data, provided the female partner does not withdraw from the study.

Key educational messages will be presented using an electronic tablet highlighting key messages and will include with relevant images as visual aids. This will help to facilitate comprehension and ensure that all relevant materials are covered during each intervention session.

No Intervention: Standard antenatal care
Pregnant women will be tested and encouraged to bring their male partners to the antenatal clinic for testing. The couples will be offered the relevant components of the intervention at the final study visit, 6 months postpartum.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   14 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Females:

  • > 14 weeks gestation
  • ≥ 14 years old (all pregnant females 14-17 years old are emancipated minors per Kenyan law)
  • Current stable partnership (married or cohabiting)
  • Planning on living in vicinity (approx. 20 km or less from clinic) for 9 months postpartum
  • Willing to be randomized to intervention or standard of care
  • Willing to participate in couple HIV testing and counseling
  • No recent history of intimate partner violence (within last month with their current partner)
  • Male partner not present during screening visit

Males:

  • ≥ 18 years old
  • Willing to participate in couple HIV testing and counseling

Exclusion Criteria:

Females:

  • ≤ 14 weeks gestation
  • < 14 years old (all pregnant females 14-17 years old are emancipated minors per Kenyan law)
  • Not in a current stable partnership (not married or not cohabiting)
  • Not planning on living in vicinity (approx. 20 km or less from clinic) for 9 months postpartum
  • Recent history of intimate partner violence (within last month with their current partner)
  • Unwilling to be randomized to intervention or standard of care
  • Unwilling to participate in couple HIV testing and counseling
  • Male partner present during screening visit

Males:

  • < 18 years old
  • Unwilling to participate in couple HIV testing and counseling
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01784783

Locations
Kenya
Kisumu District Hospital
Kisumu, Nyanza, Kenya, 40100
Sponsors and Collaborators
University of Washington
Investigators
Principal Investigator: Carey Farquhar, MD MPH University of Washington
Study Director: Daisy Krakowiak, MPH University of Washington
  More Information

No publications provided

Responsible Party: Carey Farquhar, Associate Professor, University of Washington
ClinicalTrials.gov Identifier: NCT01784783     History of Changes
Other Study ID Numbers: 44357-A, R01HD075108-01
Study First Received: February 4, 2013
Last Updated: October 10, 2013
Health Authority: Kenya: Ethical Review Committee
United States: Institutional Review Board

Keywords provided by University of Washington:
Exclusive breastfeeding
HIV transmission
PMTCT
Discordancy
Home-based testing
Couple counseling
Couple testing
Facility delivery
Family planning
Postpartum contraceptives
Linkage to care
ART initiation

ClinicalTrials.gov processed this record on April 17, 2014