Alcohol Drinking, Cost Effectiveness, HIV, Hypertension, Maternal Child Health
Conditions
Keywords
PrEP, PEP, HIV Treatment and Prevention, Community Health, Mobile Populations, Youth and Adolescents
Brief summary
The randomized trials in this record will assess effectiveness, fidelity and cost of prevention and treatment interventions for HIV and hypertension with the objective of informing a population-based study of multi-sectored, multi-disease interventions for HIV.
Detailed description
The study will conduct randomized trials to assess effectiveness, fidelity and cost of prevention and treatment interventions. The study will conduct two randomization trials to evaluate dynamic treatment interventions tailored to the needs of heavy alcohol users and mobile populations. The study will conduct three randomized trials to evaluate dynamic choice prevention interventions delivered in the context of antenatal clinics, the outpatient department, and in the community delivered by village health teams. The trial will conduct a randomized trial to evaluate a linkage intervention for patients with hypertension and a randomized trial to evaluate a clinic vs. community based intervention for hypertension.
Interventions
OTHERMobility Dynamic Treatment Intervention
1\) Access to a mobility coordinator who will assist with transfers, rescheduling, and out-of-facility refills; 2) Provision of a travel pack with alternative ART packaging options (e.g. ziplock bags, envelopes, pill boxes), a packing list and mobility coordinator phone contact for unplanned travel; 3) Screening at every clinic visit for planned mobility; 4) Mobile number and mobile minutes for unexpected travel; 5) Provision of longer refills (up to 6-months) for planned travel
OTHERHealth Living Intervention for Heavy Alcohol Users
1\) Two in-person alcohol counseling sessions with support from a clinical psychologist; 2) Monthly booster phone calls
OTHERHypertension Linkage
1\) Travel voucher (financial incentive) conditional on linkage to hypertensive care; 2) Phone call reminders for missed visits
OTHERPrEP/PEP at Outpatient Clinics
Intervention delivered at Outpatient Clinics: Counseling and education on and choice between prevention modalities (e.g. PrEP, PEP, condoms), choice of service location, provision of a clinical officer's or nurse's mobile telephone number for immediate PEP starts any day of the week, routine assessment of barriers to initiation or adherence to PrEP/PEP, including the offer of personalized potential solutions such as choice of in-clinic or offsite service delivery, psychologic supports for traumatic experiences, and offer of concurrent, additional health or prevention related services
OTHERPrEP/PEP at Antenatal Clinics
Intervention delivered at Antenatal Clinics: Counseling and education on and choice between prevention modalities (e.g. PrEP, PEP, condoms), choice of service location, provision of a clinical officer's or nurse's mobile telephone number for immediate PEP starts any day of the week, routine assessment of barriers to initiation or adherence to PrEP/PEP, including the offer of personalized potential solutions such as choice of in-clinic or offsite service delivery, psychologic supports for traumatic experiences, and offer of concurrent, additional health or prevention related services
OTHERPrEP/PEP at Community Households
Intervention delivered in community by village health team: Counseling and education on and choice between prevention modalities (e.g. PrEP, PEP, condoms), choice of service location, provision of a clinical officer's or nurse's mobile telephone number for immediate PEP starts any day of the week, routine assessment of barriers to initiation or adherence to PrEP/PEP, including the offer of personalized potential solutions such as choice of in-clinic or offsite service delivery, psychologic supports for traumatic experiences, and offer of concurrent, additional health or prevention related services
OTHERStandard of Care
Local country standard of care protocols
OTHERHypertension Community
Hypertension care delivered at home with clinician telehealth, facilitated by lay health worker to measure blood pressure and deliver medications
Sponsors
Infectious Diseases Research Collaboration, Uganda
Makerere University
Kenya Medical Research Institute
University of California, Berkeley
University College, London
University of Pennsylvania
National Institute of Allergy and Infectious Diseases (NIAID)
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
National Institute of Mental Health (NIMH)
National Heart, Lung, and Blood Institute (NHLBI)
University of California, San Francisco
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Intervention model description
Parallel randomized trials to assess effectiveness, fidelity and cost of prevention and treatment interventions.
Eligibility
Sex/Gender
ALL
Age
15 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
INDIVIDUAL LEVEL INCLUSION CRITERIA FOR COMPONENT INTERVENTIONS PrEP/PEP at Outpatient Clinics 1. Age ≥15 years 2. HIV-negative 3. Current or anticipated risk for HIV-infection PrEP/PEP at Antenatal Clinics 1. Age ≥15 years 2. HIV-negative 3. Current or anticipated risk for HIV-infection PrEP/PEP at Community Households 1. Age \> 15 years 2. HIV-negative 3. Current or anticipated risk for HIV-infection Mobility Dynamic Treatment Intervention 1. Age ≥15 years 2. HIV-positive 3. HIV RNA non-suppression (\>400 c/mL in the prior 12 months) or missed 2 visits in past 12 months or missed 2 visits in past 12 months or no VL measured in past 12 months 4. Travel outside the community ≥2 times in past 12 months 5. Enrolled or new to care in a study clinic Healthy Living Intervention for Heavy Alcohol Users 1. Age ≥18 years 2. HIV-positive 3. HIV RNA non-suppression (\>400 c/mL in the prior 12 months) or missed clinic visits (\>2 weeks or \<=90 days from last scheduled clinic visit) within past 6 months, or out of care without return to care (\>90 days from last scheduled clinic visit) within past 6 months 4. Heavy alcohol use per AUDIT-C tool (scores of ≥4 for men, and ≥3 for women) 5. Enrolled or new to care in a study clinic Hypertension Linkage Intervention 1. Age ≥25 years 2. Blood pressure ≥140/90 mmHg on three repeated measurements during community-based hypertension screening 3. Resident (by self-report) within catchment area of referral health center Community Hypertension Intervention 1. Age \>=40 2. Blood pressure ≥160/100 on average of 2nd and 3rd measurements at initial screening 3. Sustained blood pressure elevation to ≥140/90 at initial clinic enrollment visit INDIVIDUAL LEVEL
Exclusion criteria
FOR COMPONENT INTERVENTIONS PrEP/PEP at Outpatient Clinics 1. \<15 years of age 2. Unable to provide consent or parental co-consent as per country guidelines 3. Participation in another Phase A RCT intervention component PrEP/PEP at Antenatal Clinics 1. \<15 years of age 2. unable to provide consent or parental co-consent as per country guidelines 3. Participation in another Phase A RCT intervention component PrEP/PEP at Community Households 1. \<15 years of age 2. unable to provide consent or parental co-consent as per country guidelines 3. Participation in another Phase A RCT intervention component Mobility Dynamic Treatment intervention 1. \<15 years of age 2. Participation in another Phase A RCT intervention component Healthy Living Intervention for Heavy Alcohol Users 1. \<18 years of age 2. Participation in another Phase A RCT intervention component 3. No access to mobile phone Hypertension Linkage Intervention 1. \<25 years of age 2. Plan to out-migrate from the catchment area of referral health center within 30 days of screening visit 3. Already engaged in hypertensive care (by self-report) 4. Blood pressure measure of ≥180/110 mmHg during screening symptoms of hypertensive emergency Community Hypertension Intervention 1. Pregnancy 2. Co-morbidities that preclude home monitoring
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Prevention Coverage Defined as Percentage of Follow-up Months That the Participant Used Either PrEP or PEP | 48 weeks | Primary outcome for comparison for PrEP/PEP Dynamic Prevention Intervention at outpatient clinics vs. PrEP/PEP standard of care at outpatient clinics (not applicable to other arms). Primary definition of coverage will rely on self report. |
| Prevention Coverage Defined as Percentage of Follow-up Months at Risk That the Participant is Protected From HIV Infection With Either PrEP or PEP | 48 weeks | Primary outcome for comparison for PrEP/PEP Dynamic Prevention Intervention at antenatal clinics vs. PrEP/PEP standard of care at antenatal clinics (not applicable to other arms). Primary definition of coverage will rely on self report. |
| Prevention Coverage Defined as Proportion of Follow-up Months at Risk That the Participant is Protected From HIV Infection With Either PrEP or PEP | 48 weeks | Primary outcome for comparison for PrEP/PEP Dynamic Prevention Intervention at community households vs. PrEP/PEP standard of care at community households (not applicable to other arms). Primary definition of coverage will rely on self report. |
| Number of Participants With Viral Suppression Defined by HIV RNA<400 Cps/ml | 48 weeks | Primary outcome for comparison of Mobility Dynamic Treatment intervention vs. standard of care control (not applicable to other arms). Data collected from medical records. |
| Percentage of Participants With Viral Suppression Defined by HIV RNA<400 Cps/ml | 24 weeks | Primary outcome for comparison of Healthy Living Intervention for Heavy Alcohol Users vs. standard of care control (not applicable to other arms). Data collected from medical records. |
| Number of Participants Who Linked to Hypertension Care | 30 days | Primary outcome for comparison of Hypertension linkage intervention vs. hypertension linkage control (not applicable for other arms). Linkage to hypertension care at the local government clinic within 30 days of screening positive for high blood pressure during community screening. The primary definition will rely on clinical records. |
| Percentage of Participants With Hypertension Control <140/90 mmHg | 24 weeks | Primary outcome for hypertension community treatment intervention vs. hypertension community treatment control (not applicable for other arms). Blood pressure will be measured three times using standardized procedures in all trial participants at the 24-week study visit. Hypertension is considered controlled if the average of the 2nd and 3rd measures \<140 mmHg systolic and \<90 mmHg diastolic. |
Countries
Kenya, Uganda
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| PREP/PEP at Outpatient Clinics Dynamic Prevention Intervention PrEP/PEP at Outpatient Clinics: Intervention delivered at Outpatient Clinics: Counseling and education on and choice between prevention modalities (e.g. PrEP, PEP, condoms), choice of service location, provision of a clinical officer's or nurse's mobile telephone number for immediate PEP starts any day of the week, routine assessment of barriers to initiation or adherence to PrEP/PEP, including the offer of personalized potential solutions such as choice of in-clinic or offsite service delivery, psychologic supports for traumatic experiences, and offer of concurrent, additional health or prevention related services | 197 |
| PREP/PEP at Outpatient Clinics Control Standard of Care: Local country standard of care protocols | 206 |
| PREP/PEP at Antenatal Clinics Dynamic Prevention Intervention PrEP/PEP at Antenatal Clinics: Intervention delivered at Antenatal Clinics: Counseling and education on and choice between prevention modalities (e.g. PrEP, PEP, condoms), choice of service location, provision of a clinical officer's or nurse's mobile telephone number for immediate PEP starts any day of the week, routine assessment of barriers to initiation or adherence to PrEP/PEP, including the offer of personalized potential solutions such as choice of in-clinic or offsite service delivery, psychologic supports for traumatic experiences, and offer of concurrent, additional health or prevention related services | 203 |
| PREP/PEP at Antenatal Clinics Control Standard of Care: Local country standard of care protocols | 197 |
| PREP/PEP at Community Households Dynamic Prevention Intervention PrEP/PEP at Community Households: Intervention delivered in community by village health team: Counseling and education on and choice between prevention modalities (e.g. PrEP, PEP, condoms), choice of service location, provision of a clinical officer's or nurse's mobile telephone number for immediate PEP starts any day of the week, routine assessment of barriers to initiation or adherence to PrEP/PEP, including the offer of personalized potential solutions such as choice of in-clinic or offsite service delivery, psychologic supports for traumatic experiences, and offer of concurrent, additional health or prevention related services | 212 |
| PREP/PEP at Community Households Control Standard of Care: Local country standard of care protocols | 217 |
| Mobility Dynamic Treatment Intervention Mobility Dynamic Treatment Intervention: 1) Access to a mobility coordinator who will assist with transfers, rescheduling, and out-of-facility refills; 2) Provision of a travel pack with alternative ART packaging options (e.g. ziplock bags, envelopes, pill boxes), a packing list and mobility coordinator phone contact for unplanned travel; 3) Screening at every clinic visit for planned mobility; 4) Mobile number and mobile minutes for unexpected travel; 5) Provision of longer refills (up to 6-months) for planned travel | 102 |
| Mobility Control Standard of Care: Local country standard of care protocols | 99 |
| Healthy Living for Heavy Alcohol Users Intervention Health Living Intervention for Heavy Alcohol Users: 1) Two in-person alcohol counseling sessions with support from a clinical psychologist; 2) Monthly booster phone calls | 197 |
| Heavy Alcohol Users Control Standard of Care: Local country standard of care protocols | 203 |
| Hypertension Linkage Intervention Hypertension Linkage: 1) Travel voucher (financial incentive) conditional on linkage to hypertensive care; 2) Phone call reminders for missed visits | 100 |
| Hypertension Linkage Control Standard of Care: Local country standard of care protocols | 99 |
| Hypertension Community Intervention Hypertension Community: Hypertension care delivered at home with clinician telehealth, facilitated by lay health worker to measure blood pressure and deliver medications | 98 |
| Hypertension Community Control Standard of Care: Local country standard of care protocols | 102 |
| Total | 2,232 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 | FG008 | FG009 | FG010 | FG011 | FG012 | FG013 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study | Death | 0 | 0 | 0 | 0 | 0 | 0 | 2 | 2 | 0 | 1 | 0 | 0 | 2 | 1 |
| Overall Study | Disenrolled in error | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 |
| Overall Study | Lost to Follow-up | 15 | 12 | 7 | 9 | 10 | 6 | 0 | 0 | 0 | 0 | 1 | 0 | 3 | 9 |
| Overall Study | Moved/transferred care | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 12 | 10 | 0 | 0 | 0 | 0 |
| Overall Study | Participant declined | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 2 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | PREP/PEP at Outpatient Clinics Dynamic Prevention Intervention | PREP/PEP at Outpatient Clinics Control | PREP/PEP at Antenatal Clinics Dynamic Prevention Intervention | PREP/PEP at Antenatal Clinics Control | PREP/PEP at Community Households Dynamic Prevention Intervention | PREP/PEP at Community Households Control | Mobility Dynamic Treatment Intervention | Mobility Control | Healthy Living for Heavy Alcohol Users Intervention | Heavy Alcohol Users Control | Hypertension Linkage Intervention | Hypertension Linkage Control | Hypertension Community Intervention | Hypertension Community Control | Total |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 27 years | 29 years | 24 years | 24 years | 29 years | 30 years | 38 years | 36 years | 37 years | 37 years | 57 years | 56 years | 60 years | 63 years | 34 years |
| Race/Ethnicity, Customized African | 197 Participants | 206 Participants | 203 Participants | 197 Participants | 212 Participants | 217 Participants | 102 Participants | 99 Participants | 197 Participants | 203 Participants | 100 Participants | 99 Participants | 98 Participants | 102 Participants | 2232 Participants |
| Region of Enrollment Kenya | 97 participants | 104 participants | 103 participants | 98 participants | 110 participants | 100 participants | 51 participants | 50 participants | 84 participants | 86 participants | 50 participants | 49 participants | 50 participants | 50 participants | 1082 participants |
| Region of Enrollment Uganda | 100 participants | 102 participants | 100 participants | 99 participants | 102 participants | 117 participants | 51 participants | 49 participants | 113 participants | 117 participants | 50 participants | 50 participants | 48 participants | 52 participants | 1150 participants |
| Sex: Female, Male Female | 120 Participants | 125 Participants | 203 Participants | 197 Participants | 124 Participants | 119 Participants | 56 Participants | 53 Participants | 60 Participants | 71 Participants | 60 Participants | 59 Participants | 69 Participants | 70 Participants | 1386 Participants |
| Sex: Female, Male Male | 77 Participants | 81 Participants | 0 Participants | 0 Participants | 88 Participants | 98 Participants | 46 Participants | 46 Participants | 137 Participants | 132 Participants | 40 Participants | 40 Participants | 29 Participants | 32 Participants | 846 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk | EG008 affected / at risk | EG009 affected / at risk | EG010 affected / at risk | EG011 affected / at risk | EG012 affected / at risk | EG013 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 197 | 0 / 206 | 0 / 203 | 0 / 197 | 0 / 212 | 0 / 217 | 2 / 102 | 2 / 99 | 0 / 197 | 1 / 203 | 0 / 100 | 0 / 99 | 2 / 98 | 1 / 102 |
| other Total, other adverse events | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 7 / 197 | 0 / 206 | 17 / 203 | 2 / 197 | 4 / 212 | 1 / 217 | 3 / 102 | 2 / 99 | 3 / 197 | 1 / 203 | 5 / 100 | 0 / 99 | 5 / 98 | 1 / 102 |
Outcome results
Primary
Number of Participants Who Linked to Hypertension Care
Primary outcome for comparison of Hypertension linkage intervention vs. hypertension linkage control (not applicable for other arms). Linkage to hypertension care at the local government clinic within 30 days of screening positive for high blood pressure during community screening. The primary definition will rely on clinical records.
Time frame: 30 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| PREP/PEP at Outpatient Clinics Dynamic Prevention Intervention | Number of Participants Who Linked to Hypertension Care | 96 Participants |
| PREP/PEP at Outpatient Clinics Control | Number of Participants Who Linked to Hypertension Care | 65 Participants |
Primary
Number of Participants With Viral Suppression Defined by HIV RNA<400 Cps/ml
Primary outcome for comparison of Mobility Dynamic Treatment intervention vs. standard of care control (not applicable to other arms). Data collected from medical records.
Time frame: 48 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| PREP/PEP at Outpatient Clinics Dynamic Prevention Intervention | Number of Participants With Viral Suppression Defined by HIV RNA<400 Cps/ml | 85 Participants |
| PREP/PEP at Outpatient Clinics Control | Number of Participants With Viral Suppression Defined by HIV RNA<400 Cps/ml | 83 Participants |
Primary
Percentage of Participants With Hypertension Control <140/90 mmHg
Primary outcome for hypertension community treatment intervention vs. hypertension community treatment control (not applicable for other arms). Blood pressure will be measured three times using standardized procedures in all trial participants at the 24-week study visit. Hypertension is considered controlled if the average of the 2nd and 3rd measures \<140 mmHg systolic and \<90 mmHg diastolic.
Time frame: 24 weeks
Population: Participants who completed the 24-week follow-up visit
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PREP/PEP at Outpatient Clinics Dynamic Prevention Intervention | Percentage of Participants With Hypertension Control <140/90 mmHg | 77 Percentage of persons with HTN control |
| PREP/PEP at Outpatient Clinics Control | Percentage of Participants With Hypertension Control <140/90 mmHg | 51 Percentage of persons with HTN control |
Primary
Percentage of Participants With Viral Suppression Defined by HIV RNA<400 Cps/ml
Primary outcome for comparison of Healthy Living Intervention for Heavy Alcohol Users vs. standard of care control (not applicable to other arms). Data collected from medical records.
Time frame: 24 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PREP/PEP at Outpatient Clinics Dynamic Prevention Intervention | Percentage of Participants With Viral Suppression Defined by HIV RNA<400 Cps/ml | 83 Percentage of participants with VL <400 |
| PREP/PEP at Outpatient Clinics Control | Percentage of Participants With Viral Suppression Defined by HIV RNA<400 Cps/ml | 82 Percentage of participants with VL <400 |
Primary
Prevention Coverage Defined as Percentage of Follow-up Months at Risk That the Participant is Protected From HIV Infection With Either PrEP or PEP
Primary outcome for comparison for PrEP/PEP Dynamic Prevention Intervention at antenatal clinics vs. PrEP/PEP standard of care at antenatal clinics (not applicable to other arms). Primary definition of coverage will rely on self report.
Time frame: 48 weeks
| Arm | Measure | Value (MEAN) |
|---|---|---|
| PREP/PEP at Outpatient Clinics Dynamic Prevention Intervention | Prevention Coverage Defined as Percentage of Follow-up Months at Risk That the Participant is Protected From HIV Infection With Either PrEP or PEP | 70 Percentage of months |
| PREP/PEP at Outpatient Clinics Control | Prevention Coverage Defined as Percentage of Follow-up Months at Risk That the Participant is Protected From HIV Infection With Either PrEP or PEP | 29 Percentage of months |
Primary
Prevention Coverage Defined as Percentage of Follow-up Months That the Participant Used Either PrEP or PEP
Primary outcome for comparison for PrEP/PEP Dynamic Prevention Intervention at outpatient clinics vs. PrEP/PEP standard of care at outpatient clinics (not applicable to other arms). Primary definition of coverage will rely on self report.
Time frame: 48 weeks
Population: Participants who completed the Week 48 visit.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| PREP/PEP at Outpatient Clinics Dynamic Prevention Intervention | Prevention Coverage Defined as Percentage of Follow-up Months That the Participant Used Either PrEP or PEP | 47.5 Percentage of months |
| PREP/PEP at Outpatient Clinics Control | Prevention Coverage Defined as Percentage of Follow-up Months That the Participant Used Either PrEP or PEP | 18.3 Percentage of months |
Primary
Prevention Coverage Defined as Proportion of Follow-up Months at Risk That the Participant is Protected From HIV Infection With Either PrEP or PEP
Primary outcome for comparison for PrEP/PEP Dynamic Prevention Intervention at community households vs. PrEP/PEP standard of care at community households (not applicable to other arms). Primary definition of coverage will rely on self report.
Time frame: 48 weeks
| Arm | Measure | Value (MEAN) |
|---|---|---|
| PREP/PEP at Outpatient Clinics Dynamic Prevention Intervention | Prevention Coverage Defined as Proportion of Follow-up Months at Risk That the Participant is Protected From HIV Infection With Either PrEP or PEP | 28.0 Percentage of months |
| PREP/PEP at Outpatient Clinics Control | Prevention Coverage Defined as Proportion of Follow-up Months at Risk That the Participant is Protected From HIV Infection With Either PrEP or PEP | 0.5 Percentage of months |