HIVPhase 2NCT02018978
Comprehensive Triaged HIV Prevention in Tanzania
A Phase 2 study testing Comprehensive Triaged HIV Prevention (CTHP) in people with HIV, run by Medical University of South Carolina at 1 site in Tanzania.
Trial summary
This is a 3-year Phase II trial of a HIV prevention strategy designed to significantly reduce population-level HIV incidence. The study design is a two-arm community randomized controlled trial of Comprehensive Triaged HIV Prevention (CTHP) which includes: (a) Access to an HIV center which will provide free HIV… 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?
- Comprehensive Triaged HIV Prevention (CTHP)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 739 participants
- Where
- 1 siteTanzania
- Study dates
- Oct 2013to Dec 2016
- Phase
- Phase 2
- 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
Who may be able to join
- Be between 18-55 years of age
- Lives in the household regularly
- Able to provide informed consent
- Plans on living in the study area for the duration of the study (2 years)
Who cannot join
- Younger than 18 years of age or older than 55 years of age
- Does not reside in the household regularly
- Is not able to provide informed consent
- Does not plan on living in the study area for study duration (2 years)
Trial locations and contacts
1 site in 1 country.
Tanzania1 site
Muhimbili University of Health and Allied Sciences
Dar es Salaam
About this study
Official title: Phase II RCT of Comprehensive Triaged HIV Prevention: Tanzania
This is a 3-year Phase II trial of a HIV prevention strategy designed to significantly reduce population-level HIV incidence. The study design is a two-arm community randomized controlled trial of Comprehensive Triaged HIV Prevention (CTHP) which includes: (a) Access to an HIV center which will provide free HIV testing and counseling, (b) Educational activities related to HIV risk behavior, (c) Special counseling sessions for HIV-infected clients, (d) A onetime provision of a small amount of food or health products for sex partners of persons testing positive for HIV or reporting HIV risk behaviors when they come to receive HIV testing, (e) A post test support club for persons infected with HIV, (f) An income generation training program for people testing positive for HIV, (g) Transportation assistance in visiting the HIV Care and Treatment Clinic in the area for those who test positive for HIV, and, (h) Counseling and transportation support for those on medical treatment for HIV to assist them in attending scheduled appointments, and receiving and taking their medications as recommended by the clinic staff. The study will take place within two communities located in Kisarawe district, Tanzania. The intervention will occur over an 18-month period with outcomes assessed at baseline and post-intervention. The study hypothesis is that individuals in the intervention community will have a lower incidence of sexually transmitted infections (STIs) than those in the control community.
- Conditions
- HIV
- Being tested
- Comprehensive Triaged HIV Prevention (CTHP)
- Keywords
- HIV prevention, Behavioral intervention, Community-randomized trial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Comprehensive Triaged HIV Prevention (CTHP)Behavioural
- HIV Voluntary Counseling and Testing at Community Prevention Center-The center will be open to all community members.
- Community Mobilization-HIV/AIDS and VCT information will be disseminated with pamphlets, community discussions, and meetings.
- Risk Assessment and Triaged Counseling and Recruitment-Clients identified at high-risk for HIV infection and HIV-infected clients we be offered an additional counseling session. Participation will be incentivized. These clients will also be provided with up to 3 referral cards to give to sexual partners. If partners come for VCT, they will receive a small incentive.
- Incentives \& Support Activities - Modest and ethically appropriate incentives, including those providing nutritional support (food), health and hygiene benefits (bed nets), transport to access interventions, or income generation potential, will be provided for participation in some project interventions, and these will be graduated based on HIV risk potential.
| Study group | Role | What they receive |
|---|---|---|
| CTHP | Experimental | 1. HIV Voluntary Counseling and Testing at Community Prevention Center-The center will be open to all community members.
2. Community Mobilization-HIV/AIDS and VCT information will be disseminated with pamphlets, community discussions, and meetings.
3. Risk Assessment and Triaged Counseling and Recruitment-Clients identified at high-risk for HIV infection and HIV-infected clients we be offered an additional counseling session. Participation will be incentivized. These clients will also be provided with up to 3 referral cards to give to sexual partners. If partners come for VCT, they will receive a small incentive.
4. Incentives \& Support Activities - Modest and ethically appropriate incentives, including those providing nutritional support (food), health and hygiene benefits (bed nets), transport to access interventions, or income generation potential, will be provided for participation in some project interventions, and these will be graduated based on HIV risk potential. Receives: Behavioral: Comprehensive Triaged HIV Prevention (CTHP) |
| Standard of Care | No intervention | This arm will receive standard of care HIV-related services, including clinic-based voluntary counseling and testing and referrals to HIV care and treatment government-run facilities. |
What is being measured
The primary outcome is the main question the study is designed to answer.
STI Incidence
Incidence of sexually transmitted infections (STI) defined as any incident case of syphilis, HIV, or herpes simplex virus-2.
Measured: 18 months
Secondary outcomes (2)
Safety and acceptability
Safety and acceptability of the intervention will be assessed through weekly reports detailing any adverse social or physical events related to participation in the intervention compiled by study staff.
Measured: 18 months (during intervention)
Sexual risk behavior
Sexual risk behavior will be measured by assessing condom use at last sex with each sexual partner, frequency of condom use in the last 6 months with each sexual partner, and number of sexual partners in the last 6 months.
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 posted24 Dec 2013 (estimated)
- Study startOct 2013
- Primary completionDec 2016
- Study completionDec 2016
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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 739 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Collaborators
- Muhimbili University of Health and Allied Sciences
- Responsible party
- Sponsor
- Investigators
- Michael D Sweat, PhD, Principal investigator, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02018978
- Sponsor's protocol ID
- R01MH095869
- Status last verified
- Oct 2017
- First submitted
- 17 Dec 2013
- Last updated
- 24 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II RCT of Comprehensive Triaged HIV Prevention: Tanzania
- ClinicalTrials.gov ID
- NCT02018978
- Acronym / sponsor ID
- R01MH095869
- Conditions
- HIV
- Keywords
- HIV prevention, Behavioral intervention, Community-randomized trial
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 739 participants (actual)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Collaborators
- Muhimbili University of Health and Allied Sciences
- Study start
- Oct 2013
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 24 Dec 2013 (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.
This is a 3-year Phase II trial of a HIV prevention strategy designed to significantly reduce population-level HIV incidence. The study design is a two-arm community randomized controlled trial of Comprehensive Triaged HIV Prevention (CTHP) which includes: (a) Access to an HIV center which will provide free HIV testing and counseling, (b) Educational activities related to HIV risk behavior, (c) Special counseling sessions for HIV-infected clients, (d) A onetime provision of a small amount of food or health products for sex partners of persons testing positive for HIV or reporting HIV risk behaviors when they come to receive HIV testing, (e) A post test support club for persons infected with HIV, (f) An income generation training program for people testing positive for HIV, (g) Transportation assistance in visiting the HIV Care and Treatment Clinic in the area for those who test positive for HIV, and, (h) Counseling and transportation support for those on medical treatment for HIV to assist them in attending scheduled appointments, and receiving and taking their medications as recommended by the clinic staff. The study will take place within two communities located in Kisarawe district, Tanzania. The intervention will occur over an 18-month period with outcomes assessed at baseline and post-intervention. The study hypothesis is that individuals in the intervention community will have a lower incidence of sexually transmitted infections (STIs) than those in the control community.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CTHP | Experimental | Behavioral: Comprehensive Triaged HIV Prevention (CTHP)1. HIV Voluntary Counseling and Testing at Community Prevention Center-The center will be open to all community members. 2. Community Mobilization-HIV/AIDS and VCT information will be disseminated with pamphlets, community discussions, and meetings. 3. Risk Assessment and Triaged Counseling and Recruitment-Clients identified at high-risk for HIV infection and HIV-infected clients we be offered an additional counseling session. Participation will be incentivized. These clients will also be provided with up to 3 referral cards to give to sexual partners. If partners come for VCT, they will receive a small incentive. 4. Incentives \& Support Activities - Modest and ethically appropriate incentives, including those providing nutritional support (food), health and hygiene benefits (bed nets), transport to access interventions, or income generation potential, will be provided for participation in some project interventions, and these will be graduated based on HIV risk potential. |
| Standard of Care | No intervention | –This arm will receive standard of care HIV-related services, including clinic-based voluntary counseling and testing and referrals to HIV care and treatment government-run facilities. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Be between 18-55 years of age
- Lives in the household regularly
- Able to provide informed consent
- Plans on living in the study area for the duration of the study (2 years)
Key exclusion criteria (4 listed)
- Younger than 18 years of age or older than 55 years of age
- Does not reside in the household regularly
- Is not able to provide informed consent
- Does not plan on living in the study area for study duration (2 years)
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 |
|---|---|---|
| Comprehensive Triaged HIV Prevention (CTHP)1. HIV Voluntary Counseling and Testing at Community Prevention Center-The center will be open to all community members. 2. Community Mobilization-HIV/AIDS and VCT information will be disseminated with pamphlets, community discussions, and meetings. 3. Risk Assessment and Triaged Counseling and Recruitment-Clients identified at high-risk for HIV infection and HIV-infected clients we be offered an additional counseling session. Participation will be incentivized. These clients will also be provided with up to 3 referral cards to give to sexual partners. If partners come for VCT, they will receive a small incentive. 4. Incentives \& Support Activities - Modest and ethically appropriate incentives, including those providing nutritional support (food), health and hygiene benefits (bed nets), transport to access interventions, or income generation potential, will be provided for participation in some project interventions, and these will be graduated based on HIV risk potential. | Behavioural | CTHP |
Primary outcome
STI Incidence
Time frame: 18 months
Incidence of sexually transmitted infections (STI) defined as any incident case of syphilis, HIV, or herpes simplex virus-2.
2 secondary outcomes
Safety and acceptability
Time frame: 18 months (during intervention)
Sexual risk behavior
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 24 Oct 2017.
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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.
Michael D Sweat, PhD principal investigator
Medical University of South Carolina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Comprehensive Triaged HIV Prevention (CTHP) in people with 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 4 inclusion and 4 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 24 Oct 2017. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
STI Incidence (time frame: 18 months). 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 24 Oct 2017.