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| Name | Class |
|---|---|
| Beira Operational Research Center | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Financial Incentive Group | Experimental |
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| Reminders Group | Experimental |
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| Financial Incentive and Reminders Group | Experimental |
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| Control Group | No Intervention | ||
| Information Group | Experimental |
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| Stigma-relieving Group | Experimental |
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| Information and Stigma-relieving Group | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Financial Incentive | Behavioral | Financial Incentive: Participants will receive monthly financial incentives each time they refill the ART medication on time for six months |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 0-6 month interval from date of study enrollment |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| James Riddell IV, MD | University of Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Munhava Health Center | Beira | Sofala | 2100 | Mozambique |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 10, 2018 | Sep 11, 2018 | SAP_000.pdf |
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| ID | Term |
|---|---|
| D000163 | Acquired Immunodeficiency Syndrome |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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| Reminders | Behavioral | Reminders: Participants will receive monthly reminder phone calls before their ART medication refill is due for six months. |
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| Financial Incentive and Reminders | Behavioral | Interaction: Participants receive both the Financial Incentives and Reminder Calls. |
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| Information | Behavioral | Information: show the participants a video about HIV progression, mechanism of ART, the benefit of adhering to ART. |
|
| Stigma-relieving | Behavioral | 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. |
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| Information and Stigma-relieving | Behavioral | 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. |
|
| 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. | 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. | 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. | 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. | 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. | 1 month interval from date of study enrollment |
| D015229 |
| Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012897 | Slow Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |