HIVPhase 3CASANCT01070017

Community-based Accompaniment With Supervised Antiretrovirals in Lima, Peru

A Phase 3 study testing DOT-HAART in people with HIV and AIDS, run by Brigham and Women's Hospital at 1 site in Peru.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

Using quantitative and qualitative data, this study will assess the impact of community accompaniment with supervised antiretrovirals (CASA) on HIV-positive individuals and community members in Lima, Peru. Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: HIV, AIDS, HIV Infections
What is being tested?: DOT-HAART
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 1,244 participants
Where: 1 sitePeru
Study dates: Feb 2010to Aug 2014
Phase: Phase 3
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 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Age greater than or equal to 18;
Diagnosis if HIV and meeting criteria for HAART;
Lives in poverty;
EITHER: 1) HAART naïve or 2) starting salvage therapy due to virologic failure;
Documentation of baseline CD4 cell count and HIV load;
Residence and receipt of HIV healthcare within the study catchment area
Working in a health establishments in study region;
If health personnel, contracted employee caring for people living with HIV/AIDS.

Who cannot join

Imprisoned or cannot give informed consent.
Cannot give informed consent

Trial locations and contacts

1 site in 1 country.

Peru1 site

Socios En Salud
Lima

Other trials in Peru

About this study

Read the detailed description

Community-based accompaniment with directly observed antiretroviral therapy (DOT-HAART) may improve adherence and clinical outcomes among impoverished individuals starting HAART in resource-poor settings. Furthermore, the utilization of community health workers may build social capital. This is cluster-randomized trial, with randomization at the level of health centers. Individuals in both intervention and control clusters will receive community-based adherence support (monthly adherence visits) and standard care. In addition, individuals residing in intervention clusters will receive 12 months of community-based DOT-HAART. We will enroll patients as well as community members (health providers, treatment supporters, and community health workers) to assess individual and community-level outcomes.

Conditions: HIV, AIDS, HIV Infections
Being tested: DOT-HAART
Keywords: Peru, DOT, HIV, AIDS, Community based, social capital
Medical subject headings: Acquired Immunodeficiency Syndrome, HIV Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

DOT-HAARTOther
For 8 months, DOT-HAART of all doses in the participant's home or alternate location. DOT worker ensures that HIV medications are taken as indicated and witnesses ingestion of all medications including other medications prescribed by physician. The worker will be trained to identify, triage and notify providers of any psychosocial and medical problems/complications. Transition to self-administration begins in months 9-12 when DOT will be tapered and greater participation of treatment supporter to prepare patients for self-administration.

Study groups in NCT01070017
Study group	Role	What they receive
Intervention: DOT-HAART	Experimental	Intervention group will receive community-based monthly adherence visits, standard care, and DOT-HAART. Receives: Other: DOT-HAART
No DOT-HAART	No intervention	Control group receives community-based monthly adherence visits and standard care, but no DOT-HAART.

What is being measured

The primary outcome is the main question the study is designed to answer.

Proportion with suppressed HIV viral load after starting HAART among those receiving community-based DOT-HAART versus the control group.
Measured: 18 and 24 months

Secondary outcomes (2)

Identify mediating mechanisms of CASA effect on individual outcomes.
Measured: 24 months
Identify subgroups who respond best to CASA intervention.
Measured: 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Feb 2010Aug 2014

First posted17 Feb 2010 (estimated)
Study startFeb 2010
Primary completion31 Jul 2012
Study completionAug 2014

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 Brigham and Women's HospitalThe 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 3
Primary purpose: Health services research
Allocation: Randomised
Intervention model: Parallel groups
Model description: Cluster randomization of sites assign individuals starting antiretroviral therapy to receive community-based directly observed therapy plus home visits / social support versus home visits / social support alone.
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 1,244 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01070017
Sponsor's protocol ID: 1R01MH083550-01A2
Other IDs: 1R01MH083550-01A2
Acronym: CASA
Status last verified: Oct 2017
First submitted: 16 Feb 2010
Last updated: 25 Oct 2017
Results posted: No
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All HIV trials

Study at a glance

From the registry record, last updated by the sponsor on 25 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Community-based Accompaniment With Supervised Antiretrovirals in Lima, Peru
ClinicalTrials.gov ID: NCT01070017
Acronym / sponsor ID: CASA / 1R01MH083550-01A2
Conditions: HIV, AIDS, HIV Infections
Keywords: Peru, DOT, HIV, AIDS, Community based, social capital
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,244 participants (actual)
Lead sponsor: Brigham and Women's HospitalUniversity, hospital or other
Collaborators: National Institute of Mental Health (NIMH), Partners in Health, Harvard School of Public Health (HSPH), Harvard Medical School (HMS and HSDM)
Study start: Feb 2010
Primary completion: 31 Jul 2012 (actual)
Study completion: Aug 2014 (actual)
First posted: 17 Feb 2010 (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.

Detailed description

Study design

Primary purpose: Health services research
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2
Model description: Cluster randomization of sites assign individuals starting antiretroviral therapy to receive community-based directly observed therapy plus home visits / social support versus home visits / social support alone.

Arm	Type	Receives
Intervention: DOT-HAART	Experimental	Other: DOT-HAARTIntervention group will receive community-based monthly adherence visits, standard care, and DOT-HAART.
No DOT-HAART	No intervention	–Control group receives community-based monthly adherence visits and standard care, but no DOT-HAART.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

Age greater than or equal to 18;
Diagnosis if HIV and meeting criteria for HAART;
Lives in poverty;
EITHER: 1) HAART naïve or 2) starting salvage therapy due to virologic failure;
Documentation of baseline CD4 cell count and HIV load;

Key exclusion criteria (2 listed)

Imprisoned or cannot give informed consent.
Cannot give informed consent

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
DOT-HAARTFor 8 months, DOT-HAART of all doses in the participant's home or alternate location. DOT worker ensures that HIV medications are taken as indicated and witnesses ingestion of all medications including other medications prescribed by physician. The worker will be trained to identify, triage and notify providers of any psychosocial and medical problems/complications. Transition to self-administration begins in months 9-12 when DOT will be tapered and greater participation of treatment supporter to prepare patients for self-administration.	Other	Intervention: DOT-HAART

Primary outcome

Proportion with suppressed HIV viral load after starting HAART among those receiving community-based DOT-HAART versus the control group.
Time frame: 18 and 24 months

2 secondary outcomes

Identify mediating mechanisms of CASA effect on individual outcomes.
Time frame: 24 months
Identify subgroups who respond best to CASA intervention.
Time frame: 24 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 25 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.

Sonya Shin, MD, MPH principal investigator

Brigham and Women's Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing DOT-HAART in people with HIV and AIDS, run by Brigham and Women's Hospital at 1 site in Peru.

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 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 25 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 Peru. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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?

Proportion with suppressed HIV viral load after starting HAART among those receiving community-based DOT-HAART versus the control group. (time frame: 18 and 24 months). 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 NCT01070017.

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 25 Oct 2017.