Zambia One Love Aim 3 Trial

Not Applicable

Completed

• Conditions: HIV; Non-communicable Diseases; Neglected Diseases; Sexually Transmitted Diseases
• Interventions: Behavioral: Good Health Package Plus (GHPP); Behavioral: Strengthening Our Vows (SOV)

• Registration Number: NCT02744586
• Lead Sponsor: Emory University

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.

Study Timeline

• Study Start: 2016-01
• Study First Submitted: 2016-04-15
• Study First Submitted QC: 2016-04-15
• Study First Posted: 2016-04-20
• Primary Completion: 2016-12
• Study Completion: 2016-12
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-30
• Last Update Posted: 2018-02-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3450

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

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Good Health Package Plus (GHPP) Group	Good Health Package Plus (GHPP)	Participants in the GHPP arm will receive education on the prevention of helminths, schistosomiasis, hypertension, diabetes, and diarrheal diseases through participatory and interactive group sessions.
Strengthening our Vows (SOV) Group	Strengthening Our Vows (SOV)	Participants in the SOV arm will participate in the "Together HIV Free" and "Protecting My Spouse" plans.

Primary Outcome Measures

Name	Time	Method
Number of Self-Reported Sexually Transmitted Infections (STIs)	Duration of Study (Up to six months)	The number of self-reported STIs via questionnaire.
Knowledge and use of hygiene and sanitation measures	Duration of Study (Up to six months)	Number of participants who show increased knowledge of hygiene and sanitation measures via a study specific questionnaire.
HIV Incidence Rate	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	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	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	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	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	Duration of Study (Up to six months)	The number of new laboratory confirmed vaginal trichomoniasis diagnosis.
Number of Reported Outside Partners	Duration of Study (Up to six months)	The self-reported number of sexual partners outside of marriage.

Secondary Outcome Measures

Name	Time	Method
Perceived Efficacy of Handwashing	Duration of Study (Up to six months)	The number of participants who report a perceived effect of handwashing via a study specific questionnaire.
Perceived Efficacy of Deworming	Duration of Study (Up to six months)	The number of participants who report a perceived effect of deworming via a study specific questionnaire.
Perceived Efficacy of Management of Diabetes	Duration of Study (Up to six months)	The number of participants who report a perceived effect of management of diabetes via a study specific questionnaire.
Change in Communication between Husband and Wife	Duration of Study (Up to six months)	Change in communication between husband and wife dyads regarding exposure to HIV through extramarital sexual behaviors will be measured using a study specific questionnaire.
Perceived Efficacy of Chlorine Use	Duration of Study (Up to six months)	The number of participants who report a perceived effect of chlorine use via a study specific questionnaire.
Perceived Efficacy of Management of Hypertension	Duration of Study (Up to six months)	The number of participants who report a perceived effect of management of hypertension via a study specific questionnaire.

Trial Locations

Locations (2)

Lusaka Research Site; 🇿🇲 Lusaka, Zambia

Ndola Research Site; 🇿🇲 Ndola, Copperbelt, Zambia