HIVDDCPNCT03098693
Dyadic-Based Diagnosis, Care, and Prevention for HIV Discordant Couples in Tanzania
An observational study of HIV, run by Medical University of South Carolina at 1 site in Tanzania.
Trial summary
This is a prospective observational study of couples in Kisarawe, Tanzania who will be provided an intervention that offers: (1) HIV self-testing kits and pre-test counseling provided at the household, (2) linkage to a counseling and referral center for those who test positive, (3) facilitated enrollment to care and… Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- HIV
- What is being tested?
- HIV Self-Testing, Immediate Access to ART for HIV infected couple members and Access to PrEP for HIV uninfected couple members
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 128 participants
- Where
- 1 siteTanzania
- Study dates
- 21 Nov 2017to 7 Sep 2020
- Phase
- Observational
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Cohabitating couples aged 18 to 55 years of age, residing in Kisarawe Town, Tanzania. Our cohort will be comprised of HIV sero-discordant couples.
Who may be able to join
- To be eligible for participation in the self-testing cohort, each individual has to be:
- age 18 years or older (and at least one member of the couple has to be aged 55 years or below),
- live in the household regularly,
- have no plans for moving from the area before the follow up period.
- To be eligible for the prevention and care portion of the study, couples must be:
- in an HIV sero-discordant relationship,
- pregnant or breastfeeding women will be allowed to enroll in the study after counseling on the risks and benefits is provided,
- HIV-negative women who are pregnant or breastfeeding will be allowed to take PrEP after counseling on the risks and benefits is provided.
Who cannot join
- Couples will not be eligible for enrolled in the sero-discordant sub-cohort if:
- the HIV-negative member has signs of advanced kidney disease (measured by serum creatinine),
- the HIV-negative partner has Hepatitis B and markers of poor liver functioning (measured by alanine aminotransferase).
Trial locations and contacts
1 site in 1 country.
Tanzania1 site
Muhimbili University of Health and Allied Programs
Dar Es Salaam, Pwani Region
About this study
This is a prospective observational study of couples in Kisarawe, Tanzania who will be provided an intervention that offers: (1) HIV self-testing kits and pre-test counseling provided at the household, (2) linkage to a counseling and referral center for those who test positive, (3) facilitated enrollment to care and treatment for couples with confirmed HIV infection; and (4) access to pre-exposure prophylaxis for the negative partner in a HIV sero-discordant couple. We will identify HIV sero-discordant couples through the HIV self-testing component, and through identifying discordant couples at the local HIV clinic. HIV sero-discordant couples (N=64 couples) will be administered a baseline, 6- ,12-, and 18-month survey, and the investigators will collect ongoing clinical data from each clinic visit. Biometric data (fingerprint) will be collected at enrollment, and all encounters with the counseling and referral center, and HIV treatment center, to allow linking of utilization of services with survey data.
Read the detailed description
The investigators propose to conduct a prospective observational study of cohabitating couples aged 18 years and above in Kisarawe, Tanzania who will be provided: (1) distribution of HIV self-testing kits to cohabitating couples; (2) linkage to confirmatory HIV-testing \& counseling for those who test HIV-positive; (3) facilitated enrollment to care and treatment for those couples with confirmed HIV infection; and (4) for HIV serodiscordant couples, access to PrEP for the HIV-negative partner. A baseline survey, and a follow-up survey approximately 2 weeks later and HIV test, will be administered to all couples involved in the self-testing phase of the study. A cohort of 60 to 70 HIV serodiscordant couples will receive a survey at baseline 6-, 12-, and 18-month survey, and the investigators will collect ongoing clinical data from each clinic visit. Biometric data (fingerprint) will be collected at study and intervention encounters to link utilization of services with survey data. The investigators will also enroll serodiscordant couples from patients already receiving care from the Kisarawe Care and Treatment Center (CTC).
The specific AIMS evaluate 4 key strategic goals, including:
- HIV Self-Testing for Stable Couples: (a) assess the acceptability, safety, and factors associated with uptake of HIV self-testing; and (b) determine the proportion of clients testing positive for HIV via self-testing who engage in care.
- Dyadic Engagement of Sero-Discordant Couples in Care \& Prevention: (a) establish the proportion of sero-discordant couples who will enroll in HIV care as a dyad, (b) determine the effect of dyadic care enrollment on HIV care retention and ART adherence, and (c) assess reduction in risk of acquiring HIV infection for the negative partner.
- Pre-Exposure Prophylaxis (PrEP): (a) establish the proportion and characteristics of HIV negative clients in a sero-discordant relationship who opt to take PrEP, (b) determine how engaging in ARV treatment by the positive partner affects PrEP utilization by the negative partner, and vice versa, and (c) Identify patterns and correlates of risk reduction strategies that couples in care utilize over time (abstinence, ARV for positive partner, PrEP for negative partner, condom use).
- Operational: (a) determine Dyadic-based Diagnosis, Care, \& Prevention (DDCP) program cost and economic efficiency, (b) compare DDCP to clinic-based and mobile VCT with regard to cost and efficiency for testing and linkage to care, and (c) assess the feasibility, acceptability, safety, and utility of using biometric data to track service utilization.
- Conditions
- HIV
- Being tested
- HIV Self-Testing, Immediate Access to ART for HIV infected couple members, Access to PrEP for HIV uninfected couple members
- Keywords
- Serodiscordant, Pre-exposure Prophylaxis, Self-testing, Tanzania
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HIV Self-TestingBehavioural
Access to home-based HIV self-testing kits for stable couples.
Immediate Access to ART for HIV infected couple membersBehavioural
Immediate access to ART for HIV infected couple members (per current Tanzanian standard of care).
Access to PrEP for HIV uninfected couple membersBehavioural
Access to PrEP for HIV uninfected couple members.
| Study group | Role | What they receive |
|---|---|---|
| Sero-discordant Couple Cohort | We will enroll and track a cohort of 60 serodiscordant couples (120 individuals). The HIV-positive couple members will be offered anti-retroviral therapy (ART) and the HIV-negative couple members will be offered pre-exposure prophylaxis (PrEP). We will monitor monthly clinic visits for the couple and will conduct in-depth behavioral surveys at baseline, 6-, 12-, and 18-months. Receives: Behavioral: HIV Self-Testing; Behavioral: Immediate Access to ART for HIV infected couple members; Behavioral: Access to PrEP for HIV uninfected couple members |
What is being measured
The primary outcome is the main question the study is designed to answer.
Utilization of HIV Self-Test Kits
The proportion of eligible individuals who received an HIV self-test kit who successfully used the kit within two weeks of receiving the test kit.
Measured: 2 weeks
Sharing of HIV Test Results with Primary Partner
The self-reported proportion of study participants who told their primary partner the results of the HIV test generated by the self-test kit.
Measured: 18 months
Proportion of HIV Sero-discordant Couples who Engage in HIV Care Together
Proportion of HIV Sero-discordant Couples who Engage in HIV Care Together
Measured: 18 months
Adherence to ART Among HIV Infected Members of Sero-discordant Couples
Self-reported proportion of doses of ART medication successfully taken on recommended schedule.
Measured: 18 months
Retention in ART Care
Having ≥2 outpatient visits at least 3 months apart per year
Measured: 18 months
Uptake of PrEP
Proportion of eligible HIV-uninfected cohort members who opt to take PrEP
Measured: 18 months
Uptake of ARVs
Proportion of eligible HIV-infected cohort members who opt to take ART
Measured: 18 months
Adherence to ART prescription refills among HIV infected members of sero-discordant couples
Proportion of ART prescriptions successfully filled based on pharmacy records among HIV-infected members of sero-discordant couples.
Measured: 18-Months
HIV Viral Load
Copies per mL of HIV detected in blood sample.
Measured: 18-months
Reduction in HIV-related Risk Behaviors
Self-reported number of sexual partners.
Measured: 18 months
Reduction in sex with non-primary sex partners
Any self-reported sex with non-primary sexual partner.
Measured: 18-Months
Reduction in sex acts
Self-reported number of vaginal and anal sex acts.
Measured: 18-months
Reduction in unprotected sex
Self-reported proportion of vaginal and anal sex acts in which a condom was used.
Measured: 18-months
Secondary outcomes (1)
Program cost per client served
Program cost per client served
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2017
- Study start21 Nov 2017
- Primary completion7 Sep 2020
- Study completion7 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIVStudies of the same condition, open and under way.
- More trials run by Medical University of South CarolinaThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Michael Sweat, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03098693
- Sponsor's protocol ID
- R01MH106369-01
- Other IDs
- R01MH106369
- Acronym
- DDCP
- Status last verified
- Jan 2022
- First submitted
- 22 Mar 2017
- Last updated
- 7 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dyadic-Based Diagnosis, Care, and Prevention for HIV Discordant Couples in Tanzania
- ClinicalTrials.gov ID
- NCT03098693
- Acronym / sponsor ID
- DDCP / R01MH106369-01
- Conditions
- HIV
- Keywords
- Serodiscordant, Pre-exposure Prophylaxis, Self-testing, Tanzania
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 21 Nov 2017 (actual)
- Primary completion
- 7 Sep 2020 (actual)
- Study completion
- 7 Sep 2020 (actual)
- First posted
- 4 Apr 2017 (actual)
- 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.
This is a prospective observational study of couples in Kisarawe, Tanzania who will be provided an intervention that offers: (1) HIV self-testing kits and pre-test counseling provided at the household, (2) linkage to a counseling and referral center for those who test positive, (3) facilitated enrollment to care and treatment for couples with confirmed HIV infection; and (4) access to pre-exposure prophylaxis for the negative partner in a HIV sero-discordant couple. We will identify HIV sero-discordant couples through the HIV self-testing component, and through identifying discordant couples at the local HIV clinic. HIV sero-discordant couples (N=64 couples) will be administered a baseline, 6- ,12-, and 18-month survey, and the investigators will collect ongoing clinical data from each clinic visit. Biometric data (fingerprint) will be collected at enrollment, and all encounters with the counseling and referral center, and HIV treatment center, to allow linking of utilization of services with survey data.
Detailed description
The investigators propose to conduct a prospective observational study of cohabitating couples aged 18 years and above in Kisarawe, Tanzania who will be provided: (1) distribution of HIV self-testing kits to cohabitating couples; (2) linkage to confirmatory HIV-testing \& counseling for those who test HIV-positive; (3) facilitated enrollment to care and treatment for those couples with confirmed HIV infection; and (4) for HIV serodiscordant couples, access to PrEP for the HIV-negative partner. A baseline survey, and a follow-up survey approximately 2 weeks later and HIV test, will be administered to all couples involved in the self-testing phase of the study. A cohort of 60 to 70 HIV serodiscordant couples will receive a survey at baseline 6-, 12-, and 18-month survey, and the investigators will collect ongoing clinical data from each clinic visit. Biometric data (fingerprint) will be collected at study and intervention encounters to link utilization of services with survey data. The investigators will also enroll serodiscordant couples from patients already receiving care from the Kisarawe Care and Treatment Center (CTC).
The specific AIMS evaluate 4 key strategic goals, including:
- HIV Self-Testing for Stable Couples: (a) assess the acceptability, safety, and factors associated with uptake of HIV self-testing; and (b) determine the proportion of clients testing positive for HIV via self-testing who engage in care.
- Dyadic Engagement of Sero-Discordant Couples in Care \& Prevention: (a) establish the proportion of sero-discordant couples who will enroll in HIV care as a dyad, (b) determine the effect of dyadic care enrollment on HIV care retention and ART adherence, and (c) assess reduction in risk of acquiring HIV infection for the negative partner.
- Pre-Exposure Prophylaxis (PrEP): (a) establish the proportion and characteristics of HIV negative clients in a sero-discordant relationship who opt to take PrEP, (b) determine how engaging in ARV treatment by the positive partner affects PrEP utilization by the negative partner, and vice versa, and (c) Identify patterns and correlates of risk reduction strategies that couples in care utilize over time (abstinence, ARV for positive partner, PrEP for negative partner, condom use).
- Operational: (a) determine Dyadic-based Diagnosis, Care, \& Prevention (DDCP) program cost and economic efficiency, (b) compare DDCP to clinic-based and mobile VCT with regard to cost and efficiency for testing and linkage to care, and (c) assess the feasibility, acceptability, safety, and utility of using biometric data to track service utilization.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sero-discordant Couple Cohort | – | Behavioral: HIV Self-Testing, Behavioral: Immediate Access to ART for HIV infected couple members, Behavioral: Access to PrEP for HIV uninfected couple membersWe will enroll and track a cohort of 60 serodiscordant couples (120 individuals). The HIV-positive couple members will be offered anti-retroviral therapy (ART) and the HIV-negative couple members will be offered pre-exposure prophylaxis (PrEP). We will monitor monthly clinic visits for the couple and will conduct in-depth behavioral surveys at baseline, 6-, 12-, and 18-months. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Cohabitating couples aged 18 to 55 years of age, residing in Kisarawe Town, Tanzania. Our cohort will be comprised of HIV sero-discordant couples.
Key inclusion criteria (8 listed)
- age 18 years or older (and at least one member of the couple has to be aged 55 years or below),
- live in the household regularly,
- have no plans for moving from the area before the follow up period.
- in an HIV sero-discordant relationship,
- pregnant or breastfeeding women will be allowed to enroll in the study after counseling on the risks and benefits is provided,
Key exclusion criteria (3 listed)
- the HIV-negative member has signs of advanced kidney disease (measured by serum creatinine),
- the HIV-negative partner has Hepatitis B and markers of poor liver functioning (measured by alanine aminotransferase).
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 |
|---|---|---|
| HIV Self-TestingAccess to home-based HIV self-testing kits for stable couples. | Behavioural | Sero-discordant Couple Cohort |
| Immediate Access to ART for HIV infected couple membersImmediate access to ART for HIV infected couple members (per current Tanzanian standard of care). | Behavioural | Sero-discordant Couple Cohort |
| Access to PrEP for HIV uninfected couple membersAccess to PrEP for HIV uninfected couple members. | Behavioural | Sero-discordant Couple Cohort |
Primary outcome
Utilization of HIV Self-Test Kits
Time frame: 2 weeks
The proportion of eligible individuals who received an HIV self-test kit who successfully used the kit within two weeks of receiving the test kit.
Sharing of HIV Test Results with Primary Partner
Time frame: 18 months
The self-reported proportion of study participants who told their primary partner the results of the HIV test generated by the self-test kit.
Proportion of HIV Sero-discordant Couples who Engage in HIV Care Together
Time frame: 18 months
Proportion of HIV Sero-discordant Couples who Engage in HIV Care Together
Adherence to ART Among HIV Infected Members of Sero-discordant Couples
Time frame: 18 months
Self-reported proportion of doses of ART medication successfully taken on recommended schedule.
Retention in ART Care
Time frame: 18 months
Having ≥2 outpatient visits at least 3 months apart per year
Uptake of PrEP
Time frame: 18 months
Proportion of eligible HIV-uninfected cohort members who opt to take PrEP
Uptake of ARVs
Time frame: 18 months
Proportion of eligible HIV-infected cohort members who opt to take ART
Adherence to ART prescription refills among HIV infected members of sero-discordant couples
Time frame: 18-Months
Proportion of ART prescriptions successfully filled based on pharmacy records among HIV-infected members of sero-discordant couples.
HIV Viral Load
Time frame: 18-months
Copies per mL of HIV detected in blood sample.
Reduction in HIV-related Risk Behaviors
Time frame: 18 months
Self-reported number of sexual partners.
Reduction in sex with non-primary sex partners
Time frame: 18-Months
Any self-reported sex with non-primary sexual partner.
Reduction in sex acts
Time frame: 18-months
Self-reported number of vaginal and anal sex acts.
Reduction in unprotected sex
Time frame: 18-months
Self-reported proportion of vaginal and anal sex acts in which a condom was used.
1 secondary outcome
Program cost per client served
Time frame: 18 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 7 Feb 2022.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV, run by Medical University of South Carolina at 1 site in Tanzania.
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 8 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 7 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Tanzania. 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. 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?
Utilization of HIV Self-Test Kits (time frame: 2 weeks). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Feb 2022.