HIV InfectionsCVCTNCT00631384
Experimental Design of Couple Counseling and Testing in Antenatal Clinics in Dar es Salaam, Tanzania
A study testing Couples VCT and Individual VCT in people with HIV Infections, run by Johns Hopkins Bloomberg School of Public Health at 1 site in Tanzania.
Trial summary
The objective of this research is to evaluate the effectiveness of couples Voluntary Counseling and Testing for HIV (CVCT) compared to individual VCT (IVCT) in preventing MTCT, and in increasing preventive behaviors and minimizing spousal abuse among HIV positive women. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- HIV Infections
- What is being tested?
- Couples VCT and Individual VCT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,521 participants
- Where
- 1 siteTanzania
- Study dates
- Mar 2003to Sep 2004
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Up to 6 months of pregnancy
- Currently married or in cohabiting union for 2+ years and co-resident with husband
Who cannot join
- In polygamous marriage
- 7 or more months pregnant
Trial locations and contacts
1 site in 1 country.
About this study
The objective of this research is to evaluate the effectiveness of couples Voluntary Counseling and Testing for HIV (CVCT) compared to individual VCT (IVCT) in preventing MTCT, and in increasing preventive behaviors and minimizing spousal abuse among HIV positive women. We hypothesize that offering CVCT will not decrease uptake of VCT among women. This research will be carried out in 3 antenatal clinics in Dar es Salaam, Tanzania.
- Conditions
- HIV Infections
- Being tested
- Couples VCT, Individual VCT
- Keywords
- Voluntary Counseling and Testing, HIV, HIV seronegativity
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Couples VCTBehavioural
Offer women coming to antenatal clinics to have their husbands come with them for couples VCT
Individual VCTBehavioural
Women to receive individual VCT
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Women to be asked to bring husbands for couple VCT Receives: Behavioral: Couples VCT |
| 2 | Active comparator | Women to receive individual VCT Receives: Behavioral: Individual VCT |
What is being measured
The primary outcome is the main question the study is designed to answer.
HIV Testing and receiving results
Measured: within one month of initial visit to ANC
Secondary outcomes (3)
use of nevirapine
Measured: 3 months after testing
use of protection at time of sexual intercourse
Measured: 3 months after HIV test
domestic violence
Measured: 3 months after HIV test
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2008 (estimated)
- Study startMar 2003
- Primary completionSep 2004
- Study completionSep 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by Johns Hopkins Bloomberg School of Public HealthThe 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,521 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins Bloomberg School of Public Health
- Sponsor type
- University, hospital or other
- Collaborators
- Johns Hopkins University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00631384
- Sponsor's protocol ID
- H.32.02.05.29
- Acronym
- CVCT
- Status last verified
- Apr 2018
- First submitted
- 28 Feb 2008
- Last updated
- 20 Apr 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Experimental Design of Couple Counseling and Testing in Antenatal Clinics in Dar es Salaam, Tanzania
- ClinicalTrials.gov ID
- NCT00631384
- Acronym / sponsor ID
- CVCT / H.32.02.05.29
- Conditions
- HIV Infections
- Keywords
- Voluntary Counseling and Testing, HIV, HIV seronegativity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,521 participants (actual)
- Lead sponsor
- Johns Hopkins Bloomberg School of Public HealthUniversity, hospital or other
- Collaborators
- Johns Hopkins University
- Study start
- Mar 2003
- Primary completion
- Sep 2004 (actual)
- Study completion
- Sep 2004 (actual)
- First posted
- 7 Mar 2008 (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 objective of this research is to evaluate the effectiveness of couples Voluntary Counseling and Testing for HIV (CVCT) compared to individual VCT (IVCT) in preventing MTCT, and in increasing preventive behaviors and minimizing spousal abuse among HIV positive women. We hypothesize that offering CVCT will not decrease uptake of VCT among women. This research will be carried out in 3 antenatal clinics in Dar es Salaam, Tanzania.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: Couples VCTWomen to be asked to bring husbands for couple VCT |
| 2 | Active comparator | Behavioral: Individual VCTWomen to receive individual VCT |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Up to 6 months of pregnancy
- Currently married or in cohabiting union for 2+ years and co-resident with husband
Key exclusion criteria (2 listed)
- In polygamous marriage
- 7 or more months pregnant
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 |
|---|---|---|
| Couples VCTOffer women coming to antenatal clinics to have their husbands come with them for couples VCT | Behavioural | 1 |
| Individual VCTWomen to receive individual VCT | Behavioural | 2 |
Primary outcome
HIV Testing and receiving results
Time frame: within one month of initial visit to ANC
3 secondary outcomes
use of nevirapine
Time frame: 3 months after testing
use of protection at time of sexual intercourse
Time frame: 3 months after HIV test
domestic violence
Time frame: 3 months after HIV test
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 20 Apr 2018.
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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?
A study testing Couples VCT and Individual VCT in people with HIV Infections, run by Johns Hopkins Bloomberg School of Public Health 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 2 inclusion and 2 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 20 Apr 2018. 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?
HIV Testing and receiving results (time frame: within one month of initial visit to ANC). 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 20 Apr 2018.