Zambia One Love Aim 3 Trial
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About
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.
Full description
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.
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Inclusion criteria
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
Exclusion criteria
- 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)
Trial design
Primary purpose
Allocation
Interventional model
Masking
3,450 participants in 2 patient groups, including a placebo group
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Data sourced from clinicaltrials.gov
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