A Randomized Control Study to Evaluate Novel Interventions to Reduce Risk Factors Associated With HIV, Neglected Tropical and Non-communicable Diseases Among Couples in Zambia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 3,450
- 试验地点
- 2
- 主要终点
- HIV Incidence Rate
研究概览
简要总结
The aim of this study is to determine whether a Strengthening our Vows (SOV) intervention will reduce HIV exposures from concurrent partnership (CP) when compared to the control Good Health Package Plus (GHPP), in addition to couples' voluntary HIV counseling and testing (CVCT), among concordant HIV-negative couples living in Zambia.
详细描述
This is a randomized control study to evaluate novel interventions to reduce risk factors associated with HIV, neglected tropical and non-communicable diseases among couples in Zambia.
The aim of this study is to determine whether a Strengthening our Vows (SOV) intervention will reduce HIV exposures from concurrent partnership (CP) when compared to the control Good Health Package Plus (GHPP), in addition to couples' voluntary HIV counseling and testing (CVCT), among concordant HIV-negative couples.
Investigators seeks to compare the impact of the SOV intervention and the GHPP intervention on reduction in a composite of risk factors associated with HIV acquisition from concurrent partners, compare the impact of GHPP and SOV on knowledge and use of hygiene and sanitation measures and hypertension and diabetes screening and management, and compare self-reported couples' testing (CVCT) with outside partners in the SOV and GHPP arms.
Couples will receive SOV or GHPP based on the pre-randomization of the clinic which they attend for standard of care HIV counseling and testing. The Strengthening our Vows (SOV) intervention will seek to establish a dialogue or norm where couples will be able to protect each other from HIV infection from outside partners. The Good Health Package Plus (GHPP) intervention focuses on strategies to improve household health related to diarrheal diseases, helminths, schistosomiasis, diabetes, and hypertension.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Heterosexual Zambian couples who have undergone CVCT as standard of care in government health clinics in Lusaka and Ndola. Couples must be women 18-45 cohabiting with men 18-65 years old, have cohabited 3 months or greater, are both HIV-negative and are able to attend the scheduled follow-up visits.
- •Heterosexual HIV-concordant negative
- •Cohabiting at least 3 months
- •Both partners at least 18 years of age (women aged 18-45, men aged 18-65)
- •Not on antiretroviral therapy including Post Exposure Prophylaxis (PEP) or Pre Exposure Prophylaxis (PrEP)
- •Interested in participating
- •Able and willing to provide informed consent (literacy is not required)
- •Willing to complete interviewer-administered questionnaires on risk factors
- •Available for follow-up for the duration of the study
- •Willing and able to be contacted via phone or home visit
- •Able and willing to provide adequate locator/contact information for retention purposes, and willing to be contacted by the study staff
排除标准
- •Presence of any condition that, in the opinion of the investigator or designee, would preclude provision of informed consent, or otherwise interfere with achieving the study objectives
- •Either partner HIV-positive or with indeterminate HIV rapid test results
- •Attendance to a clinic involved in the opposite arm of the study (i.e., test with partner at a clinic indicated as SOV but attends a clinic indicated as GHPP or vice versa)
结局指标
主要结局
HIV Incidence Rate
时间窗: Duration of Study (Up to six months)
The number of new laboratory confirmed HIV diagnosis.
Number of Reports of Sex without a Condom with Outside Partners
时间窗: Duration of Study (Up to six months)
The number of reports of sex without using a condom reported via a study specific questionnaire.
Knowledge of hypertension and diabetes screening and management
时间窗: Duration of Study (Up to six months)
Number of participants who show increased knowledge of hypertension and diabetes screening and management via a study specific questionnaire.
Syphilis Incidence Rate
时间窗: Duration of Study (Up to six months)
The number of new laboratory confirmed syphilis diagnosis.
Number of self-reports of accessing couples' testing (CVCT) with outside partners
时间窗: Duration of Study (Up to six months)
Number of participants who report accessing CVCT services with their outside partners reported via a study specific questionnaire.
Vaginal Trichomoniasis Incidence Rate
时间窗: Duration of Study (Up to six months)
The number of new laboratory confirmed vaginal trichomoniasis diagnosis.
Number of Reported Outside Partners
时间窗: Duration of Study (Up to six months)
The self-reported number of sexual partners outside of marriage.
Number of Self-Reported Sexually Transmitted Infections (STIs)
时间窗: Duration of Study (Up to six months)
The number of self-reported STIs via questionnaire.
Knowledge and use of hygiene and sanitation measures
时间窗: Duration of Study (Up to six months)
Number of participants who show increased knowledge of hygiene and sanitation measures via a study specific questionnaire.
次要结局
- Perceived Efficacy of Deworming(Duration of Study (Up to six months))
- Perceived Efficacy of Handwashing(Duration of Study (Up to six months))
- Perceived Efficacy of Management of Diabetes(Duration of Study (Up to six months))
- Change in Communication between Husband and Wife(Duration of Study (Up to six months))
- Perceived Efficacy of Chlorine Use(Duration of Study (Up to six months))
- Perceived Efficacy of Management of Hypertension(Duration of Study (Up to six months))