HIVNCT02744586
Zambia One Love Aim 3 Trial
A study testing Strengthening Our Vows (SOV) and Good Health Package Plus (GHPP) in people with HIV and Sexually Transmitted Diseases, run by Emory University at 2 sites in Zambia.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- HIV, Sexually Transmitted Diseases, Neglected Diseases
- What is being tested?
- Strengthening Our Vows (SOV) and Good Health Package Plus (GHPP)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 3,450 participants
- Where
- 2 sitesZambia
- Study dates
- Jan 2016to Dec 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 11Show fewer
- 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
Who cannot join
- 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)
Trial locations and contacts
2 sites in 1 country.
About this study
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
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.
Read the 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.
- Being tested
- Strengthening Our Vows (SOV), Good Health Package Plus (GHPP)
- Keywords
- Sexually transmitted infections, Neglected tropical diseases, Non-communicable diseases
- Medical subject headings
- Sexually Transmitted Diseases, Neglected Diseases, Noncommunicable Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Strengthening Our Vows (SOV)Behavioural
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)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Strengthening our Vows (SOV) Group | Experimental | Participants in the SOV arm will participate in the "Together HIV Free" and "Protecting My Spouse" plans. Receives: 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. Receives: Behavioral: Good Health Package Plus (GHPP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
HIV Incidence Rate
The number of new laboratory confirmed HIV diagnosis.
Measured: Duration of Study (Up to six months)
Syphilis Incidence Rate
The number of new laboratory confirmed syphilis diagnosis.
Measured: Duration of Study (Up to six months)
Vaginal Trichomoniasis Incidence Rate
The number of new laboratory confirmed vaginal trichomoniasis diagnosis.
Measured: Duration of Study (Up to six months)
Number of Self-Reported Sexually Transmitted Infections (STIs)
The number of self-reported STIs via questionnaire.
Measured: 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.
Measured: Duration of Study (Up to six months)
Number of Reported Outside Partners
The self-reported number of sexual partners outside of marriage.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Duration of Study (Up to six months)
Secondary outcomes (6)
Perceived Efficacy of Chlorine Use
The number of participants who report a perceived effect of chlorine use via a study specific questionnaire.
Measured: Duration of Study (Up to six months)
Perceived Efficacy of Handwashing
The number of participants who report a perceived effect of handwashing via a study specific questionnaire.
Measured: Duration of Study (Up to six months)
Perceived Efficacy of Deworming
The number of participants who report a perceived effect of deworming via a study specific questionnaire.
Measured: Duration of Study (Up to six months)
Perceived Efficacy of Management of Diabetes
The number of participants who report a perceived effect of management of diabetes via a study specific questionnaire.
Measured: Duration of Study (Up to six months)
Perceived Efficacy of Management of Hypertension
The number of participants who report a perceived effect of management of hypertension via a study specific questionnaire.
Measured: Duration of Study (Up to six months)
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.
Measured: Duration of Study (Up to six months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2016 (estimated)
- Study startJan 2016
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIVStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 3,450 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Susan Allen, Emory University
- Investigators
- Susan Allen, MD, MPH, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02744586
- Sponsor's protocol ID
- IRB00083001
- Status last verified
- Jan 2018
- First submitted
- 15 Apr 2016
- Last updated
- 1 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 37024634
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02744586
- Acronym / sponsor ID
- IRB00083001
- Keywords
- Sexually transmitted infections, Neglected tropical diseases, Non-communicable diseases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3,450 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 20 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Strengthening our Vows (SOV) Group | Experimental | Behavioral: Strengthening Our Vows (SOV)Participants in the SOV arm will participate in the "Together HIV Free" and "Protecting My Spouse" plans. |
| Good Health Package Plus (GHPP) Group | Placebo comparator | Behavioral: Good Health Package Plus (GHPP)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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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)
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Strengthening our Vows (SOV) Group |
| 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. | Behavioural | Good Health Package Plus (GHPP) Group |
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.
Knowledge of hypertension and diabetes screening and management
Time frame: Duration of Study (Up to six months)
Number of participants who show increased knowledge of hypertension and diabetes screening and management via a study specific questionnaire.
Number of self-reports of accessing couples' testing (CVCT) with outside partners
Time frame: Duration of Study (Up to six months)
Number of participants who report accessing CVCT services with their outside partners reported via a study specific questionnaire.
6 secondary outcomes
Perceived Efficacy of Chlorine Use
Time frame: Duration of Study (Up to six months)
Perceived Efficacy of Handwashing
Time frame: Duration of Study (Up to six months)
Perceived Efficacy of Deworming
Time frame: Duration of Study (Up to six months)
Perceived Efficacy of Management of Diabetes
Time frame: Duration of Study (Up to six months)
Perceived Efficacy of Management of Hypertension
Time frame: Duration of Study (Up to six months)
Change in Communication between Husband and Wife
Time frame: Duration of Study (Up to six months)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2018.
- Derived from this study: PubMed 37024634Sharkey 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.
- Individual participant dataSharing planned: No
Related trials for HIV
RecruitingObservational study
Olfactory Function and Model-Based Behavior in People Living With HIV and SUD
HIV, Substance Use Disorder
Not yet recruiting
Adapting the ESTEEM Intervention to Improve Mental Health and PrEP Uptake Among Men at Risk of HIV
PrEP Use
RecruitingPhase 2
Evaluating the Safety and Immunogenicity of MTBVAC
HIV I Infection, Tuberculosis
Active, not recruiting
Evaluating the Effectiveness of a Mobile HIV Prevention App to Increase HIV and Sexually Transmitted Infections (STI) Testing and PrEP Initiation Among Rural Men Who Have Sex With Men
HIV Infections, STI
Not yet recruiting
PNF RCT to Decrease Alcohol Use and Increase HIV Prevention
HIV (Human Immunodeficiency Virus), Alcohol Misuse
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Susan Allen, MD, MPH principal investigator
Emory University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Strengthening Our Vows (SOV) and Good Health Package Plus (GHPP) in people with HIV and Sexually Transmitted Diseases, run by Emory University at 2 sites in Zambia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Zambia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HIV Incidence Rate (time frame: Duration of Study (Up to six months)). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02744586, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2018.