Back to resultsZambia One Love Aim 3 Trial
Primary Purpose
HIV, Sexually Transmitted Diseases, Neglected Diseases
Status
Completed
Phase
Not Applicable
Locations
Zambia
Study Type
Interventional
Intervention
Strengthening Our Vows (SOV)
Good Health Package Plus (GHPP)
Sponsored by
About this trial
This is an interventional health services research trial for HIV focused on measuring Sexually transmitted infections, Neglected tropical diseases, Non-communicable diseases
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)
Sites / Locations
- Ndola Research Site
- Lusaka Research Site
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Strengthening our Vows (SOV) Group
Good Health Package Plus (GHPP) Group
Arm Description
Participants in the SOV arm will participate in the "Together HIV Free" and "Protecting My Spouse" plans.
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.
Outcomes
Primary Outcome Measures
HIV Incidence Rate
The number of new laboratory confirmed HIV diagnosis.
Syphilis Incidence Rate
The number of new laboratory confirmed syphilis diagnosis.
Vaginal Trichomoniasis Incidence Rate
The number of new laboratory confirmed vaginal trichomoniasis diagnosis.
Number of Self-Reported Sexually Transmitted Infections (STIs)
The number of self-reported STIs via questionnaire.
Number of Reports of Sex without a Condom with Outside Partners
The number of reports of sex without using a condom reported via a study specific questionnaire.
Number of Reported Outside Partners
The self-reported number of sexual partners outside of marriage.
Knowledge and use of hygiene and sanitation measures
Number of participants who show increased knowledge of hygiene and sanitation measures via a study specific questionnaire.
Knowledge of hypertension and diabetes screening and management
Number of participants who show increased knowledge of hypertension and diabetes screening and management via a study specific questionnaire.
Number of self-reports of accessing couples' testing (CVCT) with outside partners
Number of participants who report accessing CVCT services with their outside partners reported via a study specific questionnaire.
Secondary Outcome Measures
Perceived Efficacy of Chlorine Use
The number of participants who report a perceived effect of chlorine use via a study specific questionnaire.
Perceived Efficacy of Handwashing
The number of participants who report a perceived effect of handwashing via a study specific questionnaire.
Perceived Efficacy of Deworming
The number of participants who report a perceived effect of deworming via a study specific questionnaire.
Perceived Efficacy of Management of Diabetes
The number of participants who report a perceived effect of management of diabetes via a study specific questionnaire.
Perceived Efficacy of Management of Hypertension
The number of participants who report a perceived effect of management of hypertension via a study specific questionnaire.
Change in Communication between Husband and Wife
Change in communication between husband and wife dyads regarding exposure to HIV through extramarital sexual behaviors will be measured using a study specific questionnaire.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02744586
Brief Title
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
2. Study Status
Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
January 2016 (undefined)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
December 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Emory University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV, Sexually Transmitted Diseases, Neglected Diseases, Non-communicable Diseases
Keywords
Sexually transmitted infections, Neglected tropical diseases, Non-communicable diseases
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
3450 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Strengthening our Vows (SOV) Group
Arm Type
Experimental
Arm Description
Participants in the SOV arm will participate in the "Together HIV Free" and "Protecting My Spouse" plans.
Arm Title
Good Health Package Plus (GHPP) Group
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Strengthening Our Vows (SOV)
Intervention Description
Participants, led by a counselor, will discuss options to keep HIV from entering their relationship including both sex partners remaining monogamous, using condoms every time they have sex with outside partners, and being tested together with outside partners to ensure they are HIV negative (Together HIV Free Plan). Participants will discuss options in the event of an outside exposure to HIV including abstaining from having sex with their spouse or by using condoms every time they have sex with their spouse until they can be retested for HIV after 30 days (Protecting my Spouse Plan).
Participants will be screened for hypertension, diabetes, schistosomiasis, HIV, syphilis, and trichomonas vaginalis and the presence of sperm (women only). Health problems will be treated or referred. Couples will be administered questionnaires that record self-report of sexually transmitted infections, number of outside partners, and reports of sex without a condom with outside partners.
Intervention Type
Behavioral
Intervention Name(s)
Good Health Package Plus (GHPP)
Intervention Description
Participants, led by a counselor, will discuss how to prevent, screen, and treat neglected tropical diseases (helminths and schistosomiasis), non-communicable diseases (hypertension and diabetes) and diarrheal diseases through basic hygiene and sanitation. The facilitator will demonstrate proper handwashing techniques and chlorination of water and discuss diet and lifestyle changes. Participants will be screened for hypertension, diabetes, schistosomiasis, HIV, syphilis, and trichomonas vaginalis and the presence of sperm (women only). Health problems will be treated or referred. Couples will also be administered questionnaires that record self-report of sexually transmitted infections, number of outside partners, and reports of sex without a condom with outside partners.
Primary Outcome Measure Information:
Title
HIV Incidence Rate
Description
The number of new laboratory confirmed HIV diagnosis.
Time Frame
Duration of Study (Up to six months)
Title
Syphilis Incidence Rate
Description
The number of new laboratory confirmed syphilis diagnosis.
Time Frame
Duration of Study (Up to six months)
Title
Vaginal Trichomoniasis Incidence Rate
Description
The number of new laboratory confirmed vaginal trichomoniasis diagnosis.
Time Frame
Duration of Study (Up to six months)
Title
Number of Self-Reported Sexually Transmitted Infections (STIs)
Description
The number of self-reported STIs via questionnaire.
Time Frame
Duration of Study (Up to six months)
Title
Number of Reports of Sex without a Condom with Outside Partners
Description
The number of reports of sex without using a condom reported via a study specific questionnaire.
Time Frame
Duration of Study (Up to six months)
Title
Number of Reported Outside Partners
Description
The self-reported number of sexual partners outside of marriage.
Time Frame
Duration of Study (Up to six months)
Title
Knowledge and use of hygiene and sanitation measures
Description
Number of participants who show increased knowledge of hygiene and sanitation measures via a study specific questionnaire.
Time Frame
Duration of Study (Up to six months)
Title
Knowledge of hypertension and diabetes screening and management
Description
Number of participants who show increased knowledge of hypertension and diabetes screening and management via a study specific questionnaire.
Time Frame
Duration of Study (Up to six months)
Title
Number of self-reports of accessing couples' testing (CVCT) with outside partners
Description
Number of participants who report accessing CVCT services with their outside partners reported via a study specific questionnaire.
Time Frame
Duration of Study (Up to six months)
Secondary Outcome Measure Information:
Title
Perceived Efficacy of Chlorine Use
Description
The number of participants who report a perceived effect of chlorine use via a study specific questionnaire.
Time Frame
Duration of Study (Up to six months)
Title
Perceived Efficacy of Handwashing
Description
The number of participants who report a perceived effect of handwashing via a study specific questionnaire.
Time Frame
Duration of Study (Up to six months)
Title
Perceived Efficacy of Deworming
Description
The number of participants who report a perceived effect of deworming via a study specific questionnaire.
Time Frame
Duration of Study (Up to six months)
Title
Perceived Efficacy of Management of Diabetes
Description
The number of participants who report a perceived effect of management of diabetes via a study specific questionnaire.
Time Frame
Duration of Study (Up to six months)
Title
Perceived Efficacy of Management of Hypertension
Description
The number of participants who report a perceived effect of management of hypertension via a study specific questionnaire.
Time Frame
Duration of Study (Up to six months)
Title
Change in Communication between Husband and Wife
Description
Change in communication between husband and wife dyads regarding exposure to HIV through extramarital sexual behaviors will be measured using a study specific questionnaire.
Time Frame
Duration of Study (Up to six months)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Susan Allen, MD, MPH
Organizational Affiliation
Emory University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ndola Research Site
City
Ndola
State/Province
Copperbelt
Country
Zambia
Facility Name
Lusaka Research Site
City
Lusaka
Country
Zambia
12. IPD Sharing Statement
Plan to Share IPD
No
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Zambia One Love Aim 3 Trial
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