NCT02744586

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,450

participants targeted

Target at P75+ for not_applicable hiv

Timeline
Completed

Started Jan 2016

Shorter than P25 for not_applicable hiv

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 15, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 20, 2016

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

February 1, 2018

Status Verified

January 1, 2018

Enrollment Period

11 months

First QC Date

April 15, 2016

Last Update Submit

January 30, 2018

Conditions

HIVSexually Transmitted DiseasesNeglected DiseasesNon-communicable Diseases

Keywords

Sexually transmitted infectionsNeglected tropical diseasesNon-communicable diseases

Outcome Measures

Primary Outcomes (9)

  • HIV Incidence Rate

    The number of new laboratory confirmed HIV diagnosis.

    Duration of Study (Up to six months)

  • Syphilis Incidence Rate

    The number of new laboratory confirmed syphilis diagnosis.

    Duration of Study (Up to six months)

  • Vaginal Trichomoniasis Incidence Rate

    The number of new laboratory confirmed vaginal trichomoniasis diagnosis.

    Duration of Study (Up to six months)

  • Number of Self-Reported Sexually Transmitted Infections (STIs)

    The number of self-reported STIs via questionnaire.

    Duration of Study (Up to six months)

  • 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.

    Duration of Study (Up to six months)

  • Number of Reported Outside Partners

    The self-reported number of sexual partners outside of marriage.

    Duration of Study (Up to six months)

  • 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.

    Duration of Study (Up to six months)

  • 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.

    Duration of Study (Up to six months)

  • 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.

    Duration of Study (Up to six months)

Secondary Outcomes (6)

  • Perceived Efficacy of Chlorine Use

    Duration of Study (Up to six months)

  • Perceived Efficacy of Handwashing

    Duration of Study (Up to six months)

  • Perceived Efficacy of Deworming

    Duration of Study (Up to six months)

  • Perceived Efficacy of Management of Diabetes

    Duration of Study (Up to six months)

  • Perceived Efficacy of Management of Hypertension

    Duration of Study (Up to six months)

  • +1 more secondary outcomes

Study Arms (2)

Strengthening our Vows (SOV) Group

EXPERIMENTAL

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

Behavioral: Strengthening Our Vows (SOV)

Good Health Package Plus (GHPP) Group

PLACEBO COMPARATOR

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.

Behavioral: Good Health Package Plus (GHPP)

Interventions

Strengthening Our Vows (SOV)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.

Strengthening our Vows (SOV) Group
Good Health Package Plus (GHPP)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.

Good Health Package Plus (GHPP) Group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Ndola Research Site

Ndola, Copperbelt, Zambia

Location

Lusaka Research Site

Lusaka, Zambia

Location

Related Publications (1)

  • 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.

    PMID: 37024634DERIVED

MeSH Terms

Conditions

Sexually Transmitted DiseasesNeglected DiseasesNoncommunicable Diseases

Condition Hierarchy (Ancestors)

Communicable DiseasesInfectionsGenital DiseasesUrogenital DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Susan Allen, MD, MPH

    Emory University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 15, 2016

First Posted

April 20, 2016

Study Start

January 1, 2016

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

February 1, 2018

Record last verified: 2018-01

Data Sharing

IPD Sharing
Will not share

Locations

ZA(2)