Clinical trial NCT02744586: Zambia One Love Aim 3 Trial
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV
Sexually Transmitted Diseases
Neglected Diseases
Non-communicable Diseases
Keywords: Sexually transmitted infections
Neglected tropical diseases
Non-communicable diseases
Lead sponsor: Emory University
Sponsor class: OTHER
First posted: 2016-04-20
Enrollment: 3450
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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)

Primary outcomes:
measure: HIV Incidence Rate
timeFrame: Duration of Study (Up to six months)
measure: Syphilis Incidence Rate
timeFrame: Duration of Study (Up to six months)
measure: Vaginal Trichomoniasis Incidence Rate
timeFrame: Duration of Study (Up to six months)
measure: Number of Self-Reported Sexually Transmitted Infections (STIs)
timeFrame: Duration of Study (Up to six months)
measure: Number of Reports of Sex without a Condom with Outside Partners
timeFrame: Duration of Study (Up to six months)
measure: Number of Reported Outside Partners
timeFrame: Duration of Study (Up to six months)
measure: Knowledge and use of hygiene and sanitation measures
timeFrame: Duration of Study (Up to six months)
measure: Knowledge of hypertension and diabetes screening and management
timeFrame: Duration of Study (Up to six months)
measure: Number of self-reports of accessing couples' testing (CVCT) with outside partners
timeFrame: Duration of Study (Up to six months)
Secondary outcomes:
measure: Perceived Efficacy of Chlorine Use
timeFrame: Duration of Study (Up to six months)
measure: Perceived Efficacy of Handwashing
timeFrame: Duration of Study (Up to six months)
measure: Perceived Efficacy of Deworming
timeFrame: Duration of Study (Up to six months)
measure: Perceived Efficacy of Management of Diabetes
timeFrame: Duration of Study (Up to six months)
measure: Perceived Efficacy of Management of Hypertension
timeFrame: Duration of Study (Up to six months)
measure: Change in Communication between Husband and Wife
timeFrame: Duration of Study (Up to six months)
Other outcomes:
Locations:
city: Ndola
country: Zambia
facility: Ndola Research Site
state: Copperbelt
city: Lusaka
country: Zambia
facility: Lusaka Research Site
Study officials:
affiliation: Emory University
name: Susan Allen, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: