HIV Testing and Educating Male Partners to Improve Maternal and Infant Outcomes: Home-based Partner Education and Testing (HOPE) Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 601
- 试验地点
- 2
- 主要终点
- Male self-report of uptake of HIV testing
研究概览
简要总结
The purpose of this study is to investigate the impacts of home-based couple HIV-testing and counseling and male partner education on partner HIV testing 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. 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 higher uptake of male partner HIV testing, couple testing and disclosure of HIV status. The investigators also hypothesize that there will be benefits to HIV-infected and HIV-uninfected women and their children who will have improved uptake of interventions to improve maternal and child health. 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.
详细描述
- Study design:
The proposed study is a randomized clinical trial to determine the effect of offering home-based partner education and testing (HOPE) to pregnant women. Up to 600 women will be enrolled and randomly assigned to the HOPE intervention (home-based partner education and testing - HOPE) and INVITE arms (clinic invitation to male partner to attend couple HIV counseling and testing). Women will be recruited into the study when they present for routine antenatal care. 2. Study Area Description:
This proposed trial will be carried out in and around Kisumu, located in Western Kenya, in collaboration with Kisumu District (now County) Hospital. This site has been selected because it has a high volume of new antenatal visits (~200/month), and high HIV prevalence among women presenting for antenatal care (~9.5-12%), which correlates with high HIV-1 incidence in this population. This will enable us to achieve the necessary number of outcome events in the desired timeframe. Kisumu District Hospital provides HIV testing to women and couples and offers PMTCT interventions to pregnant and postpartum HIV-1-infected women according to the Kenya Ministry of Health guidelines, which include ART when indicated. The facility adheres to the Kenyan national infant feeding policy and provides infant feeding counseling for pregnant and lactating women and their partners, emphasizing the benefits of breastfeeding and advocating for exclusive breastfeeding during infants first 6 months of life. 3. Sample Method:
Women will be recruited at the antenatal clinic at Kisumu District Hospital. All consenting women who report for care at the clinic will be screened, and all who are eligible will be invited to participate (continuous enrollment). 4. Recruitment:
Women will present to the antenatal clinic at Kisumu District Hospital, at which point they will be introduced to the study by study nurses and verbally asked for permission to be screened for eligibility. (A waiver of written consent is requested for screening.) Women who agree will be screened for eligibility, and eligible women will be invited to complete the consent process and provide written consent as a prerequisite for participation in the study. Scripts regarding information about the study and invitation to the study, which will be used by study nurses, are included in the screening forms, found in the appendix.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 14 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •> 8 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. 40 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
- •≥ 18 years old
- •Willing to participate in couple HIV testing and counseling
排除标准
- •≤ 8 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. 40 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
- •< 18 years old
- •Unwilling to participate in couple HIV testing and counseling
结局指标
主要结局
Male self-report of uptake of HIV testing
时间窗: 6 months postpartum
For both arms, male partners will be asked to report whether they received HIV testing during the course of the study.
次要结局
- Male self-report of male condom use(Enrollment and 6 months postpartum)
- Male self-report of ART initiation(6 months postpartum)
- Female self-report of delivery location(6 weeks postpartum)
- Male self-report of linkage to HIV care(6 months postpartum)
- Female self-report of exclusive breastfeeding(6 weeks, 14 weeks, and 6 months postpartum)
- Awareness of partner HIV status (intervention arm)(Enrollment to 6 months postpartum)
- Male self-report of adherence to antiretroviral treatment(6 months postpartum)
- Female self-report of initiation of prophylaxis(6 weeks postpartum)
- Female self-report of adherence to antiretroviral treatment(Enrollment to 6 weeks, 14 weeks, and 6 months postpartum)
- Female self-report of delivery assistance(6 weeks postpartum)
- Female self-report of date of first receptive intercourse after delivery(6 weeks, 14 weeks, and 6 months postpartum)
- Self-report of condom use during last sexual intercourse (male and female)(Enrollment, 6 weeks postpartum, 14 weeks postpartum, 6 months)
- Male self-report of linkage to HIV care for CD4 testing(6 months postpartum)
- Female self-report of Nevirapine treatment for infants(6 weeks, 14 weeks, 6 months postpartum)
- Female report of infant adherence to Nevirapine(6 weeks, 14 weeks, and 6 months postpartum)
- Female self-report of initiation of antiretroviral treatment(Enrollment to 6 weeks, 14 weeks, and 6 months postpartum)
- Female self-report of introduction of foods other than breastmilk(Delivery date to 6 weeks, 14 weeks, and 6 months postpartum)
- Self report of number of sexual partners (female and male)(Enrollment and 6 months postpartum)
- Female report of male condom use(Enrollment to 6 weeks, 14 weeks, and 6 months postpartum)
- Female self-report of contraceptive use(6 weeks, 14 weeks, 6 months postpartum)
- Awareness of partner HIV-status(6 months postpartum)
- Female self-report of infant mortality(Delivery to 6 weeks, 14 weeks, and 6 months postpartum)
研究者
Carey Farquhar
Associate Professor
University of Washington