Human Immunodeficiency Virus (HIV) InfectionNCT03618511
Interventions to Improve HIV Antiretroviral Therapy Adherence
A study testing Financial Incentive, Reminders and Financial Incentive and Reminders in people with Human Immunodeficiency Virus (HIV) Infection, run by University of Michigan at 1 site in Mozambique.
Trial summary
This study will explore whether financial incentives, reminders, information about HIV/AIDS and its treatment and anti-stigma counseling help improve anti-retroviral therapy (ART) adherence among HIV infected individuals in a resource-limited environment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Human Immunodeficiency Virus (HIV) Infection
- What is being tested?
- Financial Incentive, Reminders and Financial Incentive and Reminders
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 914 participants
- Where
- 1 siteMozambique
- Study dates
- 6 Aug 2018to 30 Apr 2021
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Infected with HIV;
- Have not start ART, or started ART less than 90 days before;
- Have a phone number on which can discuss private health matters.
Who cannot join
- Not infected with HIV;
- On ART for more than 90 days;
- Do not have a private phone.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Interventions to Improve HIV Antiretroviral Therapy Adherence in Sofala Province Mozambique
This study will explore whether financial incentives, reminders, information about HIV/AIDS and its treatment and anti-stigma counseling help improve anti-retroviral therapy (ART) adherence among HIV infected individuals in a resource-limited environment. The interventions will be randomized in the study population in a cross-cutting design, with a control group, a financial incentive treatment group, a reminders treatment group, a treatment group that receives both the financial incentive and reminder interventions. In addition, there will be an information treatment group, a stigma-relieving treatment group and a group that receives both information and stigma-relieving interventions. The primary outcomes of interest for this study will be the adherence to ART, measured by attendance rates at clinic appointments and refill collection rates.
- Being tested
- Financial Incentive, Reminders, Financial Incentive and Reminders, Information, Stigma-relieving
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Financial IncentiveBehavioural
Financial Incentive: Participants will receive monthly financial incentives each time they refill the ART medication on time for six months
RemindersBehavioural
Reminders: Participants will receive monthly reminder phone calls before their ART medication refill is due for six months.
Financial Incentive and RemindersBehavioural
Interaction: Participants receive both the Financial Incentives and Reminder Calls.
InformationBehavioural
Information: show the participants a video about HIV progression, mechanism of ART, the benefit of adhering to ART.
Stigma-relievingBehavioural
Stigma-Reliving: Upon recruitment, inform the participants of the results of a recent population survey regarding people's attitudes towards HIV, if they overestimate the social stigma related to HIV. This intervention intends to reduce the stigma-concern faced by the patients.
Information and Stigma-relievingBehavioural
Information and Stigma-relieving: Upon recruitment, show the participants a video about HIV progression, mechanism of ART, the benefit of adhering to ART. In addition, inform the participants of the results of a recent population survey regarding people's attitudes towards HIV, if they overestimate the social stigma related to HIV. This intervention intends to reduce the stigma-concern faced by the patients.
| Study group | Role | What they receive |
|---|---|---|
| Financial Incentive Group | Experimental | Not described Receives: Behavioral: Financial Incentive |
| Reminders Group | Experimental | Not described Receives: Behavioral: Reminders |
| Financial Incentive and Reminders Group | Experimental | Not described Receives: Behavioral: Financial Incentive and Reminders |
| Control Group | No intervention | Not described |
| Information Group | Experimental | Not described Receives: Behavioral: Information |
| Stigma-relieving Group | Experimental | Not described Receives: Behavioral: Stigma-relieving |
| Information and Stigma-relieving Group | Experimental | Not described Receives: Behavioral: Information and Stigma-relieving |
What is being measured
The primary outcome is the main question the study is designed to answer.
Medication possession ratio (MPR) at least 95%, 6 month window
Fraction of participants for whom MPR is greater than or equal to 95%. MPR is proportion of days that a respondent is in possession of at least one ART dose. MPR is computed from pharmacy dispensing records. Measurement window truncated to last visit date for patients who transfer clinics, opt out of future study participation, or die.
Measured: 0-6 month interval from date of study enrollment
Secondary outcomes (6)
Medication possession ratio (MPR) at least 95%, 3 month window
Fraction of participants for whom MPR is greater than or equal to 95%. MPR is proportion of days that a respondent is in possession of at least one ART dose. MPR is computed from pharmacy dispensing records. Measurement window truncated to last visit date for patients who transfer clinics, opt out of future study participation, or die.
Measured: 0-3 month interval from date of study enrollment
Medication possession ratio (MPR) at least 80%, 6 month window
Fraction of participants for whom MPR is greater than or equal to 80%. MPR is proportion of days that a respondent is in possession of at least one ART dose. MPR is computed from pharmacy dispensing records. Measurement window truncated to last visit date for patients who transfer clinics, opt out of future study participation, or die.
Measured: 0-6 month interval from date of study enrollment
Medication possession ratio (MPR) at least 80%, 3 month window
Fraction of participants for whom MPR is greater than or equal to 80%. MPR is proportion of days that a respondent is in possession of at least one ART dose. MPR is computed from pharmacy dispensing records. Measurement window truncated to last visit date for patients who transfer clinics, opt out of future study participation, or die.
Measured: 0-3 month interval from date of study enrollment
Appointment attendance rate (AAR)
Average AAR among participants. AAR is proportion of scheduled visits completed during the observation period. "Completed visit" considered done if patient visits clinic on scheduled appointment date, or up to 7 days prior to that date. AAR is computed from clinic records. Measurement window truncated to last visit date for patients who transfer clinics, opt out of future study participation, or die.
Measured: 0-6 month interval from date of study enrollment
Lost to follow-up (LTFU)
Fraction of participants lost to follow up (LTFU). LTFU indicates patient missed last appointment and 90 or more days have elapsed since patient's last scheduled appointment date, with no clinic record of contact since that date. Patients who transfer clinics or opt out of future study participation are excluded from LTFU denominator, but those who die are retained in LTFU denominator.
Measured: 0-6 month interval from date of study enrollment
Test Referral, 1-month window
This is a binary variable, which takes value 1 if the participant has a successful referral to test for HIV within 1 month of recruitment and 0 otherwise. A participant is considered having a successful referral if someone approaches our study team in the clinic, present us with the proof of an HIV testing together with the barcode-card we distributed to the participant upon recruitment.
Measured: 1 month interval from date of study enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2018
- Study start6 Aug 2018
- Primary completion30 Apr 2021
- Study completion30 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Human Immunodeficiency Virus (HIV) InfectionStudies of the same condition, open and under way.
- More trials run by University of MichiganThe 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
- None (open label)
- Enrolment
- 914 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- Beira Operational Research Center
- Responsible party
- Principal investigator, James Riddell, University of Michigan
- Investigators
- James Riddell IV, MD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03618511
- Sponsor's protocol ID
- HUM00133179
- Status last verified
- Sep 2021
- First submitted
- 1 Aug 2018
- Last updated
- 24 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interventions to Improve HIV Antiretroviral Therapy Adherence in Sofala Province Mozambique
- ClinicalTrials.gov ID
- NCT03618511
- Acronym / sponsor ID
- HUM00133179
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 914 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- Beira Operational Research Center
- Study start
- 6 Aug 2018 (actual)
- Primary completion
- 30 Apr 2021 (actual)
- Study completion
- 30 Apr 2021 (actual)
- First posted
- 7 Aug 2018 (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 study will explore whether financial incentives, reminders, information about HIV/AIDS and its treatment and anti-stigma counseling help improve anti-retroviral therapy (ART) adherence among HIV infected individuals in a resource-limited environment. The interventions will be randomized in the study population in a cross-cutting design, with a control group, a financial incentive treatment group, a reminders treatment group, a treatment group that receives both the financial incentive and reminder interventions. In addition, there will be an information treatment group, a stigma-relieving treatment group and a group that receives both information and stigma-relieving interventions. The primary outcomes of interest for this study will be the adherence to ART, measured by attendance rates at clinic appointments and refill collection rates.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Financial Incentive Group | Experimental | Behavioral: Financial Incentive |
| Reminders Group | Experimental | Behavioral: Reminders |
| Financial Incentive and Reminders Group | Experimental | Behavioral: Financial Incentive and Reminders |
| Control Group | No intervention | – |
| Information Group | Experimental | Behavioral: Information |
| Stigma-relieving Group | Experimental | Behavioral: Stigma-relieving |
| Information and Stigma-relieving Group | Experimental | Behavioral: Information and Stigma-relieving |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Infected with HIV;
- Have not start ART, or started ART less than 90 days before;
- Have a phone number on which can discuss private health matters.
Key exclusion criteria (3 listed)
- Not infected with HIV;
- On ART for more than 90 days;
- Do not have a private phone.
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 |
|---|---|---|
| Financial IncentiveFinancial Incentive: Participants will receive monthly financial incentives each time they refill the ART medication on time for six months | Behavioural | Financial Incentive Group |
| RemindersReminders: Participants will receive monthly reminder phone calls before their ART medication refill is due for six months. | Behavioural | Reminders Group |
| Financial Incentive and RemindersInteraction: Participants receive both the Financial Incentives and Reminder Calls. | Behavioural | Financial Incentive and Reminders Group |
| InformationInformation: show the participants a video about HIV progression, mechanism of ART, the benefit of adhering to ART. | Behavioural | Information Group |
| Stigma-relievingStigma-Reliving: Upon recruitment, inform the participants of the results of a recent population survey regarding people's attitudes towards HIV, if they overestimate the social stigma related to HIV. This intervention intends to reduce the stigma-concern faced by the patients. | Behavioural | Stigma-relieving Group |
| Information and Stigma-relievingInformation and Stigma-relieving: Upon recruitment, show the participants a video about HIV progression, mechanism of ART, the benefit of adhering to ART. In addition, inform the participants of the results of a recent population survey regarding people's attitudes towards HIV, if they overestimate the social stigma related to HIV. This intervention intends to reduce the stigma-concern faced by the patients. | Behavioural | Information and Stigma-relieving Group |
Primary outcome
Medication possession ratio (MPR) at least 95%, 6 month window
Time frame: 0-6 month interval from date of study enrollment
Fraction of participants for whom MPR is greater than or equal to 95%. MPR is proportion of days that a respondent is in possession of at least one ART dose. MPR is computed from pharmacy dispensing records. Measurement window truncated to last visit date for patients who transfer clinics, opt out of future study participation, or die.
6 secondary outcomes
Medication possession ratio (MPR) at least 95%, 3 month window
Time frame: 0-3 month interval from date of study enrollment
Medication possession ratio (MPR) at least 80%, 6 month window
Time frame: 0-6 month interval from date of study enrollment
Medication possession ratio (MPR) at least 80%, 3 month window
Time frame: 0-3 month interval from date of study enrollment
Appointment attendance rate (AAR)
Time frame: 0-6 month interval from date of study enrollment
Lost to follow-up (LTFU)
Time frame: 0-6 month interval from date of study enrollment
Test Referral, 1-month window
Time frame: 1 month interval from date of study enrollment
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 Sep 2021.
- 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.
James Riddell IV, MD principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Financial Incentive, Reminders and Financial Incentive and Reminders in people with Human Immunodeficiency Virus (HIV) Infection, run by University of Michigan at 1 site in Mozambique.
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 3 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 24 Sep 2021. 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 Mozambique. 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?
Medication possession ratio (MPR) at least 95%, 6 month window (time frame: 0-6 month interval from date of study enrollment). 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 Sep 2021.