HIV Clinical 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
Verified date | January 2018 |
Source | Emory University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 3450 |
Est. completion date | December 2016 |
Est. primary completion date | December 2016 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility |
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) |
Country | Name | City | State |
---|---|---|---|
Zambia | Lusaka Research Site | Lusaka | |
Zambia | Ndola Research Site | Ndola | Copperbelt |
Lead Sponsor | Collaborator |
---|---|
Emory University |
Zambia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | HIV Incidence Rate | The number of new laboratory confirmed HIV diagnosis. | Duration of Study (Up to six months) | |
Primary | Syphilis Incidence Rate | The number of new laboratory confirmed syphilis diagnosis. | Duration of Study (Up to six months) | |
Primary | Vaginal Trichomoniasis Incidence Rate | The number of new laboratory confirmed vaginal trichomoniasis diagnosis. | Duration of Study (Up to six months) | |
Primary | Number of Self-Reported Sexually Transmitted Infections (STIs) | The number of self-reported STIs via questionnaire. | Duration of Study (Up to six months) | |
Primary | 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) | |
Primary | Number of Reported Outside Partners | The self-reported number of sexual partners outside of marriage. | Duration of Study (Up to six months) | |
Primary | 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) | |
Primary | 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) | |
Primary | 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 | Perceived Efficacy of Chlorine Use | The number of participants who report a perceived effect of chlorine use via a study specific questionnaire. | Duration of Study (Up to six months) | |
Secondary | Perceived Efficacy of Handwashing | The number of participants who report a perceived effect of handwashing via a study specific questionnaire. | Duration of Study (Up to six months) | |
Secondary | Perceived Efficacy of Deworming | The number of participants who report a perceived effect of deworming via a study specific questionnaire. | Duration of Study (Up to six months) | |
Secondary | Perceived Efficacy of Management of Diabetes | The number of participants who report a perceived effect of management of diabetes via a study specific questionnaire. | Duration of Study (Up to six months) | |
Secondary | Perceived Efficacy of Management of Hypertension | The number of participants who report a perceived effect of management of hypertension via a study specific questionnaire. | Duration of Study (Up to six months) | |
Secondary | 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. | Duration of Study (Up to six months) |
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