Zambia One Love Aim 3 Trial

NCT ID: NCT02744586

Last Updated: 2018-02-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 3450 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-01-31
• Study Completion Date: 2016-12-31

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.

Conditions

HIV; Sexually Transmitted Diseases; Neglected Diseases; Non-communicable Diseases

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Strengthening our Vows (SOV) Group

Participants in the SOV arm will participate in the "Together HIV Free" and "Protecting My Spouse" plans.

Group Type: EXPERIMENTAL

Strengthening Our Vows (SOV)

Intervention Type: BEHAVIORAL

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.

Good Health Package Plus (GHPP) Group

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.

Group Type: PLACEBO_COMPARATOR

Good Health Package Plus (GHPP)

Intervention Type: BEHAVIORAL

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.

Interventions

Strengthening Our Vows (SOV)

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

Good Health Package Plus (GHPP)

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.

Intervention Type: BEHAVIORAL

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Emory University

OTHER

Sponsor Role: lead

Responsible Party

Susan Allen

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Susan Allen, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Emory University

Locations

Ndola Research Site

Ndola, Copperbelt, Zambia

Lusaka Research Site

Lusaka, , Zambia

Countries

Zambia

References

Sharkey T, Parker R, Wall KM, Malama K, Pappas-DeLuca K, Tichacek A, Peeling R, Kilembe W, Inambao M, Allen S. Use of "Strengthening Our Vows" Video Intervention to Encourage Negotiated Explicit Sexual Agreements in Zambian Heterosexual HIV Seroconcordant-Negative Couples. Arch Sex Behav. 2023 Aug;52(6):2649-2667. doi: 10.1007/s10508-023-02590-x. Epub 2023 Apr 6.

Reference Type: DERIVED

PMID: 37024634 (View on PubMed)

Other Identifiers

IRB00083001

Identifier Type: -

Identifier Source: org_study_id