HIV InfectionsNCT00006439
Effects of Home Visits on Medication Adherence in Children and Youth With HIV
A study testing Counseling in the home in people with HIV Infections, run by National Center for Research Resources (NCRR) at 1 site in United States.
Trial summary
Adherence to complex medication regimens is critical to successful treatment of HIV infection. Unfortunately, adherence to medical regimens with conventional interventions averages 50% in chronic disease. Read more about this study
- Who is it for?
- Ages 0 to 24 years
- Conditions the study is for
- HIV Infections
- What is being tested?
- Counseling in the home
- Type of treatment
- Lifestyle or therapy programme
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Start not givento not given
- 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 0 to 24 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- HIV positive
- English speaking
- Live in Denver metro area
- Taking >=1 antiretroviral medication
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Adherence to complex medication regimens is critical to successful treatment of HIV infection. Unfortunately, adherence to medical regimens with conventional interventions averages 50% in chronic disease. We have observed that adherence barriers that were unrecognized by providers in the clinic setting have been detected during home visits. It is possible that recognition and interventions to resolve adherence barriers observed during home visits may improve adherence. This proposal will test the hypothesis that home-visits which identify previously unrecognized adherence barriers and provide support and education will increase medication adherence among children and youth with HIV infection and improve the patient/health care provider relationship. Specific aims of the study are: 1. Determine the impact of a series of home-visits on adherence to medication regimens for HIV infected youth and children. 1a. Adherence to medical regimens will be assessed before and after the series of home-visits using a self-report questionnaire and Microelectronic Monitoring System (MEMS) or in-home pill count. 1b. For each of these measures a percentage of adherence will be calculated and compared from a baseline to after the final home visit and after the six month follow up period. 2. Assess the changes in patient satisfaction from baseline to after the home-visits using a questionnaire completed by the patient/family. 3. Incorporate a pilot study to assess the changes in the provider's knowledge of the patient's family characteristics and home circumstances relevant to adherence following the home visits.
- Conditions
- HIV Infections
- Being tested
- Counseling in the home
- Keywords
- HIV
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Counseling in the homeBehavioural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2000 (estimated)
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.
- 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
- Early clinical test
- Allocation
- Not applicable
- Intervention model
- Single group
Sponsor and investigators
- Lead sponsor
- National Center for Research Resources (NCRR)
- Sponsor type
- US National Institutes of Health
- Investigators
- Elizabeth McFarland, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00006439
- Sponsor's protocol ID
- NCRR-M01RR00069-0622
- Other IDs
- M01RR000069
- Status last verified
- Nov 2001
- First submitted
- 4 Nov 2000
- Last updated
- 24 Jun 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Home Visits on Medication Adherence in Children and Youth With HIV
- ClinicalTrials.gov ID
- NCT00006439
- Acronym / sponsor ID
- NCRR-M01RR00069-0622
- Conditions
- HIV Infections
- Keywords
- HIV
- Study type
- Interventional
- Recruitment status
- Unknown status
- Lead sponsor
- National Center for Research Resources (NCRR)US National Institutes of Health
- First posted
- 6 Nov 2000 (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.
Adherence to complex medication regimens is critical to successful treatment of HIV infection. Unfortunately, adherence to medical regimens with conventional interventions averages 50% in chronic disease. We have observed that adherence barriers that were unrecognized by providers in the clinic setting have been detected during home visits. It is possible that recognition and interventions to resolve adherence barriers observed during home visits may improve adherence. This proposal will test the hypothesis that home-visits which identify previously unrecognized adherence barriers and provide support and education will increase medication adherence among children and youth with HIV infection and improve the patient/health care provider relationship. Specific aims of the study are: 1. Determine the impact of a series of home-visits on adherence to medication regimens for HIV infected youth and children. 1a. Adherence to medical regimens will be assessed before and after the series of home-visits using a self-report questionnaire and Microelectronic Monitoring System (MEMS) or in-home pill count. 1b. For each of these measures a percentage of adherence will be calculated and compared from a baseline to after the final home visit and after the six month follow up period. 2. Assess the changes in patient satisfaction from baseline to after the home-visits using a questionnaire completed by the patient/family. 3. Incorporate a pilot study to assess the changes in the provider's knowledge of the patient's family characteristics and home circumstances relevant to adherence following the home visits.
Study design
- Primary purpose
- Early clinical test
- Allocation
- Not applicable
- Intervention model
- Single group
Who may qualify
- Ages
- 0 to 24 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- HIV positive
- English speaking
- Live in Denver metro area
- Taking >=1 antiretroviral medication
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Counseling in the home | Behavioural | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2005.
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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.
Elizabeth McFarland principal investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Counseling in the home in people with HIV Infections, run by National Center for Research Resources (NCRR) at 1 site in United States.
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 0 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: status not confirmed, as of the sponsor's last update on 24 Jun 2005. 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 United States. 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?
Results are not available in the source record.
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.
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 Jun 2005.