Zambia One Love Aim 3 Trial
Condition: HIV; Sexually Transmitted Diseases; Neglected Diseases; Non-communicable Diseases
MeSH terms: Sexually Transmitted Diseases; Noncommunicable Diseases; Neglected Diseases
Study type: Interventional

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.
    

Intervention name(s): Strengthening Our Vows (SOV); Good Health Package Plus (GHPP)
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 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.; 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Sexually transmitted infections; Neglected tropical diseases; Non-communicable diseases