Alcohol Use, Unspecified, HIV/AIDS
Conditions
Brief summary
The EXTEND study is a randomized controlled trial to compare the uptake and acceptability, efficacy, and cost of methods of delivery of an alcohol intervention in reducing unhealthy alcohol use and increasing viral suppression among HIV positive persons in Uganda. The study arms are (a) in-person counseling during 2 quarterly clinic visits plus live booster phone calls every three weeks in the interim (b) in-person counseling during 2 quarterly clinic visits plus tech (choice of SMS or IVR) boosters once to twice weekly in the interim; and (c) standard of care (SOC) control (brief unstructured advice, with a wait-listed intervention).
Detailed description
Alcohol consumption is a critical driver of HIV outcomes, especially in sub-Saharan Africa (SSA), where both are extremely common. Heavy alcohol use has been associated with reduced antiretroviral adherence, decreased HIV suppression, and increased mortality among those with HIV. Thus, reducing unhealthy alcohol use may improve HIV outcomes and is a high priority worldwide. Screening and brief counseling for alcohol use, especially multi-session approaches, have shown evidence for reducing alcohol use in resource rich settings and among persons with HIV. However, there are significant cost and human resource barriers to multiple session interventions in SSA, and it is not known whether alcohol interventions can improve HIV outcomes. Thus, the long-term goal of the EXTEND study is to develop and test interventions to reduce alcohol consumption and improve HIV outcomes, that can be feasibly integrated into routine HIV care in SSA. Multi-session interventions that combine in-person visits with booster phone calls to reinforce the in-person counseling have shown good efficacy. Because cell phone use in Uganda is high, phone-based booster sessions conducted in-between the in-person sessions (that coincide with regularly scheduled clinic visits) may be feasible. However, phone-based booster sessions delivered by a live counselor (live boosters) can be costly, time-consuming, limited to working hours, and dependent on good phone connections. Alternatively, automated cell phone-based booster sessions (tech boosters), can be conducted via interactive systems such as two-way Short Message Service (SMS, i.e. text messaging) or Interactive Voice Response (IVR) that allow for brief interactive sessions, with messages that are tailored to the participants' drinking goals and gender. Such automated tailored mobile phone-based interventions have been successful in improving several health behaviors in diverse populations. However, the uptake, acceptability, cost, and efficacy of live and tech booster calls for interventions for reducing alcohol use and improving HIV outcomes in SSA is not known. The investigators hypothesize that automated mobile phone-based technology can be leveraged as an efficacious way to implement multi-session alcohol interventions at a low burden and cost to both providers and patients in low resource settings. Objectives The EXTEND study is a randomized controlled trial (RCT) with a goal of estimating the uptake and acceptability, preliminary efficacy, and cost of methods of delivery of an intervention to reduce unhealthy drinking and HIV viral failure among persons in HIV care in rural Uganda (n=270). The RCT study arms are: 1. in-person counseling during 2 quarterly clinic visits plus live booster phone calls every three weeks in the interim; 2. in-person counseling during 2 quarterly clinic visits plus tech (choice of SMS or IVR) boosters once to twice weekly in the interim; and 3. standard of care (SOC) control (brief unstructured advice, with a wait-listed intervention). This study will be conducted in a large rural Ugandan HIV clinic. The end products of this study will be the preliminary comparisons of key outcomes to estimate effect sizes and inform the design of a future large-scale trial. The long-term aim is to implement interventions that reduce alcohol use and improve HIV outcomes feasibly and at low cost in low resource settings.
Interventions
BEHAVIORALIn-person counseling session
Brief alcohol reduction counseling is provided by a trained counselor to the study participant at the HIV clinic during two sessions that are 3 months apart.
BEHAVIORALLive phone call booster session
Brief alcohol reduction counseling booster sessions every 3 weeks delivered via a live phone call from a trained counselor to the study participant given within 3 months and in between two in-person counseling sessions.
BEHAVIORALTechnology (IVR or SMS) booster session
Brief alcohol reduction counseling booster sessions once to twice a week delivered via a choice of interactive voice response (IVR) or short message service (SMS) phone technology to the study participant given within 3 months and in between two in-person counseling sessions.
Sponsors
Mbarara University of Science and Technology
Syracuse University
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
University of California, San Francisco
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Masking description
The Research Assistant, who will collect study data including the study questionnaire and biological specimens for testing, will be blinded to the participants' study arm assignment.
Intervention model description
Participants will be randomized to 1 of 3 arms. After the trial, participants in the standard of care arm, will be offered the intervention.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age 18 years and older; * HIV positive; * On ART for at least six months; * Reported alcohol use in the prior year at clinic entry; * Fluency in Runyakole; * Living within two hours travel time from the clinic; * Owning or having daily access to a cell phone; * Screening positive on the AUDIT-C
Exclusion criteria
* Plans to move out of the catchment area within 6 months; * Unable to provide informed consent. * Participation in another research study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With HIV Viral Suppression | At 9 month visit (6 months post intervention). | Undetectable HIV viral load measured through plasma HIV viral load measurements. |
| Change in Alcohol Use Measured by Self Report | At 6 and 9 month visits (3 and 6 months post intervention). | Number of days drinking in the prior 21 days, as reported on the alcohol use timeline follow-back |
| Change in Alcohol Use Measured by the Alcohol Biomarker, Phosphatidylethanol (PEth) | At 6 and 9 month visits (3 and 6 months post intervention). | Alcohol biomarker phosphatidylethanol (PEth) level will be used as an objective measure of prior 21-day alcohol use to confirm the findings obtained using self-report. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cluster of Differentiation-4 (CD4) Cell Count | At nine months (6 months post intervention). | CD4 cell count of participants measured through plasma CD4 measurements. |
| Percent of Antiretroviral Therapy (ART) Adherence in the Prior 30 Days. | At 6 and 9 month visits (3 and 6 months post intervention). | Percent self-reported antiretroviral therapy (ART) adherence in the prior 30 days. This measure was defined as the lower of two self-reported measures of ART adherence in the prior 30 days: 1. a visual analog scale: a line ranging from 0% (no doses) to 100% (all doses) on which participants indicated how many of their ART doses they had taken, and 2. the percentage of days that the participant reported taking all of their ART pills. |
| Booster Uptake - Completion | 3 months | Technology booster uptake is defined as the percentage of technology booster sessions initiated by the system, in which the participant answered all the required questions. Live booster call uptake is defined as the percentage of live booster calls attempted, that were completed by the participant. This was a descriptive analysis of the mean percentage of boosters completed per participant. |
| Booster Satisfaction - Client Satisfaction Scale-8 | At 6 month visit (3 months post intervention) | Intervention satisfaction in each arm will be assessed using the Client Satisfaction Scale-8 (CSQ-8). The CSQ-8 is an 8-item questionnaire used to assess satisfaction with services in health and human services. The response options (1. Quite dissatisfied, 2. Indifferent or mildly dissatisfied, 3. Mostly satisfied, 4. Very satisfied) range from very negative to very positive, correlating with low to high satisfaction. The scale ranges from 25-100, with higher numbers indicating higher satisfaction. |
| Booster Satisfaction - Usability | At 6 month visit (3 months post intervention). | Usability was assessed in the technology booster arm via the System Usability Scale (SUS), used to evaluate new technology, and the proportions that chose short message service (SMS, text message) over interactive voice recognition (IVR) as the mode of booster delivery, overall and by reading literacy (yes/no). The System Usability Scale is a 10-item questionnaire; raw score totals range from 0 to 40 with higher scores indicating better usability. |
| IVR Chosen as Technology Booster Mode | 3 months | Participants in the technology booster arm chose to receive the boosters via either interactive voice response (IVR) or short message service (SMS, text). We report here on the number of participants choosing IVR among technology booster arm participants overall, and by literacy status. |
| Booster Uptake - Counselor Call-back Requests | 3 months | Number of participants in the technology booster arm who requested at least one counselor call-back during their technology session. |
| Percentage of Participants With Unhealthy Alcohol Use Via the AUDIT-C. | At 6 and 9 month visits (3 and 6 months post-intervention) | Unhealthy alcohol use via the Alcohol Use Disorders Identification Test - Consumption (AUDIT-C), in the prior 3 months. The AUDIT-C ranges from 0-12. A score of 0 reflects no alcohol use; a score of 3 or higher in adult women or 4 or higher in men is considered positive for unhealthy alcohol use. |
| Number of Heavy Drinking Days in the Prior 21 Days | At 6 and 9 month visits (3 and 6 months post intervention). | The number of heavy drinking days in the prior 21 days will be defined as the number of days from the alcohol use timeline follow-back with ≥4/≥5 drinks reported by females/males, respectively, in the prior 21 days. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Cost Methodology | Live Phone Call and Technology Booster Arms: from baseline to 3 months; for SOC wait-listed participants: from 9 months to 12 months. | To determine costs, the investigators collected data to capture all relevant direct (e.g. equipment) and indirect (e.g. administrative), fixed (or 'start-up') and variable (or 'recurring') costs related to the intervention activities. Costs were differentiated by intervention component (e.g. clinic-based counseling versus remote booster sessions) and by booster session mode of delivery (i.e. live booster versus tech booster, and between SMS and IVR tech boosters). Total observed costs (US$) were collected by booster session delivery mode and divided by the number of participants who received that booster session type. That includes participants who were randomized to each arm as well as participants randomized to the standard of care (SOC) arm who received the intervention after a wait-list control period. No individual-level data were collected; because of this, no measures of dispersion exist. |
Countries
Uganda
Participant flow
Recruitment details
Study recruitment occurred from September 2019 through December 2020. 997 persons were screened; 272 unique individuals were enrolled and randomized. The first 3 people were enrolled as pilot participants and are excluded from all analyses, leaving 269 total persons for analysis.
Pre-assignment details
The first 3 individuals enrolled in the study were considered pilot participants. They were randomized to one of the three study arms separately from the randomization for the main study participants. They are excluded from all analyses.
Participants by arm
| Arm | Count |
|---|---|
| Live Phone Call Booster Arm The live phone call arm will include in-person counseling during 2 quarterly clinic visits plus live booster phone calls every three weeks in the interim.
In-person counseling session: Brief alcohol reduction counseling is provided by a trained counselor to the study participant at the HIV clinic during two sessions that are 3 months apart.
Live phone call booster session: Brief alcohol reduction counseling booster sessions every 3 weeks delivered via a live phone call from a trained counselor to the study participant given within 3 months and in between two in-person counseling sessions. | 90 |
| Technology Booster Arm The technology booster arm will include in-person counseling during 2 quarterly clinic visits plus tech (choice of SMS or IVR) boosters once to twice weekly in the interim.
In-person counseling session: Brief alcohol reduction counseling is provided by a trained counselor to the study participant at the HIV clinic during two sessions that are 3 months apart.
Technology (IVR or SMS) booster session: Brief alcohol reduction counseling booster sessions once to twice a week delivered via a choice of interactive voice response (IVR) or short message service (SMS) phone technology to the study participant given within 3 months and in between two in-person counseling sessions. | 90 |
| Standard of Care (SOC) Arm The standard of care (SOC) control (brief unstructured advice, with a wait-listed intervention). | 89 |
| Total | 269 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 5 | 3 | 5 |
| Overall Study | Pilot participant - excluded from analyses | 1 | 1 | 1 |
Baseline characteristics
| Characteristic | Technology Booster Arm | Standard of Care (SOC) Arm | Live Phone Call Booster Arm | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 3 Participants | 1 Participants | 4 Participants |
| Age, Categorical Between 18 and 65 years | 90 Participants | 85 Participants | 89 Participants | 264 Participants |
| Age, Continuous | 39.5 years | 38.5 years | 40.0 years | 39.5 years |
| Race and Ethnicity Not Collected | — | — | — | 0 Participants |
| Region of Enrollment Uganda | 90 participants | 89 participants | 90 participants | 269 participants |
| Sex: Female, Male Female | 30 Participants | 30 Participants | 33 Participants | 93 Participants |
| Sex: Female, Male Male | 60 Participants | 59 Participants | 57 Participants | 176 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 90 | 0 / 90 | 0 / 89 |
| other Total, other adverse events | 0 / 90 | 0 / 90 | 0 / 89 |
| serious Total, serious adverse events | 1 / 90 | 0 / 90 | 0 / 89 |
Outcome results
Primary
Change in Alcohol Use Measured by Self Report
Number of days drinking in the prior 21 days, as reported on the alcohol use timeline follow-back
Time frame: At 6 and 9 month visits (3 and 6 months post intervention).
Population: The overall number of participants analyzed is the number of participants with self-reported alcohol use data at 6 months or 9 months.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Live Phone Call Booster Arm | Change in Alcohol Use Measured by Self Report | At 6 month visit | 2.9 drinking days |
| Live Phone Call Booster Arm | Change in Alcohol Use Measured by Self Report | At 9 month visit | 2.2 drinking days |
| Technology Booster Arm | Change in Alcohol Use Measured by Self Report | At 6 month visit | 3.0 drinking days |
| Technology Booster Arm | Change in Alcohol Use Measured by Self Report | At 9 month visit | 2.8 drinking days |
| Standard of Care (SOC) Arm | Change in Alcohol Use Measured by Self Report | At 6 month visit | 5.5 drinking days |
| Standard of Care (SOC) Arm | Change in Alcohol Use Measured by Self Report | At 9 month visit | 5.5 drinking days |
p-value: <0.00195% CI: [2.1, 4.9]Mixed Models Analysis
p-value: <0.00195% CI: [2.2, 5.1]Mixed Models Analysis
Primary
Change in Alcohol Use Measured by the Alcohol Biomarker, Phosphatidylethanol (PEth)
Alcohol biomarker phosphatidylethanol (PEth) level will be used as an objective measure of prior 21-day alcohol use to confirm the findings obtained using self-report.
Time frame: At 6 and 9 month visits (3 and 6 months post intervention).
Population: The overall number of participants analyzed is the number of participants with PEth alcohol biomarker data at 6 months or 9 months. n = 1 SOC participant was missing PEth from their 6 month visit.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Live Phone Call Booster Arm | Change in Alcohol Use Measured by the Alcohol Biomarker, Phosphatidylethanol (PEth) | At 6 month visit | 376.9 ng/mL |
| Live Phone Call Booster Arm | Change in Alcohol Use Measured by the Alcohol Biomarker, Phosphatidylethanol (PEth) | At 9 month visit | 313.8 ng/mL |
| Technology Booster Arm | Change in Alcohol Use Measured by the Alcohol Biomarker, Phosphatidylethanol (PEth) | At 6 month visit | 506.2 ng/mL |
| Technology Booster Arm | Change in Alcohol Use Measured by the Alcohol Biomarker, Phosphatidylethanol (PEth) | At 9 month visit | 500.8 ng/mL |
| Standard of Care (SOC) Arm | Change in Alcohol Use Measured by the Alcohol Biomarker, Phosphatidylethanol (PEth) | At 6 month visit | 396.9 ng/mL |
| Standard of Care (SOC) Arm | Change in Alcohol Use Measured by the Alcohol Biomarker, Phosphatidylethanol (PEth) | At 9 month visit | 396.2 ng/mL |
p-value: 0.64395% CI: [-117.5, 190.3]Mixed Models Analysis
p-value: 0.71195% CI: [-194.8, 132.9]Mixed Models Analysis
Primary
Percentage of Participants With HIV Viral Suppression
Undetectable HIV viral load measured through plasma HIV viral load measurements.
Time frame: At 9 month visit (6 months post intervention).
Population: n = 5 participants in the live phone call booster arm and n = 3 participants in the technology booster arm were missing viral load results at their 9 month visits and are excluded from this analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Live Phone Call Booster Arm | Percentage of Participants With HIV Viral Suppression | 95.0 percentage of participants |
| Technology Booster Arm | Percentage of Participants With HIV Viral Suppression | 94.1 percentage of participants |
| Standard of Care (SOC) Arm | Percentage of Participants With HIV Viral Suppression | 92.9 percentage of participants |
p-value: 0.51595% CI: [-9.3, 4.7]Regression, Logistic
p-value: 0.80195% CI: [-8.3, 6.4]Regression, Logistic
Secondary
Booster Satisfaction - Client Satisfaction Scale-8
Intervention satisfaction in each arm will be assessed using the Client Satisfaction Scale-8 (CSQ-8). The CSQ-8 is an 8-item questionnaire used to assess satisfaction with services in health and human services. The response options (1. Quite dissatisfied, 2. Indifferent or mildly dissatisfied, 3. Mostly satisfied, 4. Very satisfied) range from very negative to very positive, correlating with low to high satisfaction. The scale ranges from 25-100, with higher numbers indicating higher satisfaction.
Time frame: At 6 month visit (3 months post intervention)
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Live Phone Call Booster Arm | Booster Satisfaction - Client Satisfaction Scale-8 | 93.3 score on scale |
| Technology Booster Arm | Booster Satisfaction - Client Satisfaction Scale-8 | 93.1 score on scale |
| Standard of Care (SOC) Arm | Booster Satisfaction - Client Satisfaction Scale-8 | 90.0 score on scale |
Secondary
Booster Satisfaction - Usability
Usability was assessed in the technology booster arm via the System Usability Scale (SUS), used to evaluate new technology, and the proportions that chose short message service (SMS, text message) over interactive voice recognition (IVR) as the mode of booster delivery, overall and by reading literacy (yes/no). The System Usability Scale is a 10-item questionnaire; raw score totals range from 0 to 40 with higher scores indicating better usability.
Time frame: At 6 month visit (3 months post intervention).
Population: System usability was assessed only within the technology booster arm.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Technology Booster Arm | Booster Satisfaction - Usability | 34.9 score on scale |
Secondary
Booster Uptake - Completion
Technology booster uptake is defined as the percentage of technology booster sessions initiated by the system, in which the participant answered all the required questions. Live booster call uptake is defined as the percentage of live booster calls attempted, that were completed by the participant. This was a descriptive analysis of the mean percentage of boosters completed per participant.
Time frame: 3 months
Population: 0 participants from the SOC arm are included here because they did not receive boosters.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Live Phone Call Booster Arm | Booster Uptake - Completion | 86.5 % boosters completed |
| Technology Booster Arm | Booster Uptake - Completion | 44.7 % boosters completed |
Secondary
Booster Uptake - Counselor Call-back Requests
Number of participants in the technology booster arm who requested at least one counselor call-back during their technology session.
Time frame: 3 months
Population: This descriptive analysis was only completed among participants in the technology booster arm.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Technology Booster Arm | Booster Uptake - Counselor Call-back Requests | 57 Participants |
Secondary
Cluster of Differentiation-4 (CD4) Cell Count
CD4 cell count of participants measured through plasma CD4 measurements.
Time frame: At nine months (6 months post intervention).
Population: CD4 count data were not collected and as such, this analysis was not completed. We had intended to extract CD4 cell counts from HIV clinic records; however, the clinic discontinued CD4 testing when viral load monitoring became routine.
Secondary
IVR Chosen as Technology Booster Mode
Participants in the technology booster arm chose to receive the boosters via either interactive voice response (IVR) or short message service (SMS, text). We report here on the number of participants choosing IVR among technology booster arm participants overall, and by literacy status.
Time frame: 3 months
Population: Participants randomized to the technology booster arm, included in this descriptive analysis overall and stratified by literacy status.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Live Phone Call Booster Arm | IVR Chosen as Technology Booster Mode | 59 Participants |
| Technology Booster Arm | IVR Chosen as Technology Booster Mode | 46 Participants |
| Standard of Care (SOC) Arm | IVR Chosen as Technology Booster Mode | 13 Participants |
Secondary
Number of Heavy Drinking Days in the Prior 21 Days
The number of heavy drinking days in the prior 21 days will be defined as the number of days from the alcohol use timeline follow-back with ≥4/≥5 drinks reported by females/males, respectively, in the prior 21 days.
Time frame: At 6 and 9 month visits (3 and 6 months post intervention).
Population: At 6 month visit: live call booster arm (n=83); technology booster arm (n=86); SOC arm (n=85).~At 9 month visit: live call booster arm (n=85); technology booster arm (n=87); SOC arm (n=84).
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Live Phone Call Booster Arm | Number of Heavy Drinking Days in the Prior 21 Days | At 6 month visit | 1.2 days |
| Live Phone Call Booster Arm | Number of Heavy Drinking Days in the Prior 21 Days | At 9 month visit | 0.6 days |
| Technology Booster Arm | Number of Heavy Drinking Days in the Prior 21 Days | At 9 month visit | 1.5 days |
| Technology Booster Arm | Number of Heavy Drinking Days in the Prior 21 Days | At 6 month visit | 1.4 days |
| Standard of Care (SOC) Arm | Number of Heavy Drinking Days in the Prior 21 Days | At 9 month visit | 3.3 days |
| Standard of Care (SOC) Arm | Number of Heavy Drinking Days in the Prior 21 Days | At 6 month visit | 3.6 days |
p-value: 0.00295% CI: [1.6, 7.3]Mixed Models Analysis
p-value: 0.00395% CI: [1.5, 7.2]Mixed Models Analysis
Secondary
Percentage of Participants With Unhealthy Alcohol Use Via the AUDIT-C.
Unhealthy alcohol use via the Alcohol Use Disorders Identification Test - Consumption (AUDIT-C), in the prior 3 months. The AUDIT-C ranges from 0-12. A score of 0 reflects no alcohol use; a score of 3 or higher in adult women or 4 or higher in men is considered positive for unhealthy alcohol use.
Time frame: At 6 and 9 month visits (3 and 6 months post-intervention)
Population: Participants included are those with AUDIT-C data available at the 6- and 9-month visits.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Live Phone Call Booster Arm | Percentage of Participants With Unhealthy Alcohol Use Via the AUDIT-C. | At 6 month visit | 43.4 percentage of participants |
| Live Phone Call Booster Arm | Percentage of Participants With Unhealthy Alcohol Use Via the AUDIT-C. | At 9 month visit | 32.9 percentage of participants |
| Technology Booster Arm | Percentage of Participants With Unhealthy Alcohol Use Via the AUDIT-C. | At 6 month visit | 46.5 percentage of participants |
| Technology Booster Arm | Percentage of Participants With Unhealthy Alcohol Use Via the AUDIT-C. | At 9 month visit | 40.2 percentage of participants |
| Standard of Care (SOC) Arm | Percentage of Participants With Unhealthy Alcohol Use Via the AUDIT-C. | At 6 month visit | 66.7 percentage of participants |
| Standard of Care (SOC) Arm | Percentage of Participants With Unhealthy Alcohol Use Via the AUDIT-C. | At 9 month visit | 69.0 percentage of participants |
p-value: <0.00195% CI: [17, 40.7]Mixed Models Analysis
p-value: <0.00195% CI: [13, 36.8]Mixed Models Analysis
Secondary
Percent of Antiretroviral Therapy (ART) Adherence in the Prior 30 Days.
Percent self-reported antiretroviral therapy (ART) adherence in the prior 30 days. This measure was defined as the lower of two self-reported measures of ART adherence in the prior 30 days: 1. a visual analog scale: a line ranging from 0% (no doses) to 100% (all doses) on which participants indicated how many of their ART doses they had taken, and 2. the percentage of days that the participant reported taking all of their ART pills.
Time frame: At 6 and 9 month visits (3 and 6 months post intervention).
Population: At 6 month visit: live call booster arm (n=83); technology booster arm (n=86); SOC arm (n=85).~At 9 month visit: live call booster arm (n=85); technology booster arm (n=87); SOC arm (n=84).
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Live Phone Call Booster Arm | Percent of Antiretroviral Therapy (ART) Adherence in the Prior 30 Days. | At 6 month visit | 92.3 adherence percentage |
| Live Phone Call Booster Arm | Percent of Antiretroviral Therapy (ART) Adherence in the Prior 30 Days. | At 9 month visit | 93.3 adherence percentage |
| Technology Booster Arm | Percent of Antiretroviral Therapy (ART) Adherence in the Prior 30 Days. | At 6 month visit | 91.6 adherence percentage |
| Technology Booster Arm | Percent of Antiretroviral Therapy (ART) Adherence in the Prior 30 Days. | At 9 month visit | 93.3 adherence percentage |
| Standard of Care (SOC) Arm | Percent of Antiretroviral Therapy (ART) Adherence in the Prior 30 Days. | At 6 month visit | 90.4 adherence percentage |
| Standard of Care (SOC) Arm | Percent of Antiretroviral Therapy (ART) Adherence in the Prior 30 Days. | At 9 month visit | 92.8 adherence percentage |
p-value: 0.6195% CI: [-3.8, 2.2]Mixed Models Analysis
p-value: 0.47495% CI: [-4.1, 1.9]Mixed Models Analysis
Other Pre-specified
Cost Methodology
To determine costs, the investigators collected data to capture all relevant direct (e.g. equipment) and indirect (e.g. administrative), fixed (or 'start-up') and variable (or 'recurring') costs related to the intervention activities. Costs were differentiated by intervention component (e.g. clinic-based counseling versus remote booster sessions) and by booster session mode of delivery (i.e. live booster versus tech booster, and between SMS and IVR tech boosters). Total observed costs (US$) were collected by booster session delivery mode and divided by the number of participants who received that booster session type. That includes participants who were randomized to each arm as well as participants randomized to the standard of care (SOC) arm who received the intervention after a wait-list control period. No individual-level data were collected; because of this, no measures of dispersion exist.
Time frame: Live Phone Call and Technology Booster Arms: from baseline to 3 months; for SOC wait-listed participants: from 9 months to 12 months.
Population: The costing analysis was conducted for the study intervention booster session mode of delivery (ie. live call, interactive voice recognition (IVR) and short message service (SMS) technology boosters). Participants from the SOC arm who received the intervention after a wait-list control period are also included here.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Live Phone Call Booster Arm | Cost Methodology | 144.27 cost (US$) per participant |
| Technology Booster Arm | Cost Methodology | 312.79 cost (US$) per participant |
| Standard of Care (SOC) Arm | Cost Methodology | 315.45 cost (US$) per participant |