Clinical Trial: Zambia One Love Aim 3 Trial

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

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

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 Summary:

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.


Sponsor: Emory University

Current Primary Outcome:

  • HIV Incidence Rate [ Time Frame: Duration of Study (Up to six months) ]
    The number of new laboratory confirmed HIV diagnosis.
  • Syphilis Incidence Rate [ Time Frame: Duration of Study (Up to six months) ]
    The number of new laboratory confirmed syphilis diagnosis.
  • Vaginal Trichomoniasis Incidence Rate [ Time Frame: Duration of Study (Up to six months) ]
    The number of new laboratory confirmed vaginal trichomoniasis diagnosis.
  • Number of Self-Reported Sexually Transmitted Infections (STIs) [ Time Frame: Duration of Study (Up to six months) ]
    The number of self-reported STIs via questionnaire.
  • Number of Reports of Sex without a Condom with Outside Partners [ Time Frame: Duration of Study (Up to six months) ]
    The number of reports of sex without using a condom reported via a study specific questionnaire.
  • Number of Reported Outside Partners [ Time Frame: Duration of Study (Up to six months) ]
    The self-reported number of sexual partners outside of marriage.
  • Knowledge and use of hygiene and sanitation measures [ Time Frame: Duration of Study (Up to six months) ]
    Number of participants who show increased knowledge of hygiene and sanitation measures via a study specific questionnaire.
  • Knowled

    Original Primary Outcome: Same as current

    Current Secondary Outcome:

    • Perceived Efficacy of Chlorine Use [ Time Frame: 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 Handwashing [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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.
    • Perceived Efficacy of Management of Hypertension [ Time Frame: 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.
    • Change in Communication between Husband and Wife [ Time Frame: 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.


    Original Secondary Outcome: Same as current

    Information By: Emory University

    Dates:
    Date Received: April 15, 2016
    Date Started: January 2016
    Date Completion:
    Last Updated: January 12, 2017
    Last Verified: January 2017