Human Immunodeficiency VirusNCT03098654
Impact of Integrated HIV/NCD Screening on HIV Testing Uptake and Engagement in HIV Care in Kisarawe, Tanzania
A study testing Blood glucose and blood pressure testing, Diet and lifestyle counseling and DM/HTN medications as needed in people with Human Immunodeficiency Virus and Diabetes Mellitus, Type 2, run by Medical University of South Carolina at 1 site in Tanzania.
Trial summary
This study focuses on the integration of HIV and NCD screening and care. The investigators will conduct a randomized controlled trial examining the efficacy and cost-effectiveness of the intervention strategy in Kisarawe District, Tanzania, a rural area 40 KM southwest of Dar es Salaam. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Human Immunodeficiency Virus, Diabetes Mellitus, Type 2, Hypertension
- What is being tested?
- Blood glucose and blood pressure testing, Diet and lifestyle counseling and DM/HTN medications as needed
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 214 participants
- Where
- 1 siteTanzania
- Study dates
- 5 Feb 2018to 5 Aug 2022
- 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
- Be aged 18 years or above.
- Recently enrolled in HIV care and treatment
Who cannot join
- Potentially vulnerable populations (incarcerated, under age of consent, unable to understand the procedures planned, etc.).
- Individuals under the influence of drugs or alcohol and anyone presenting with mental disability that would preclude ability to understand study procedure, risks, and benefits.
- Inability or unwillingness of subject to provide informed consent.
Trial locations and contacts
1 site in 1 country.
Tanzania1 site
Muhimbili University of Health and Allied Sciences
Dar es Salaam
About this study
Official title: Impact of Integrated HIV/NCD Screening on HIV Testing Uptake and Engagement in HIV Care: an RCT in Kisarawe, Tanzania
This study focuses on the integration of HIV and NCD screening and care. The investigators will conduct a randomized controlled trial examining the efficacy and cost-effectiveness of the intervention strategy in Kisarawe District, Tanzania, a rural area 40 KM southwest of Dar es Salaam. The study will match two similar HIV care and treatment centers (CTC) in the District, one of which will be randomized to receive the enhanced intervention which will integrate diabetes (DM) and hypertension (HTN) screening with the existing HIV testing program, and integrate care for DM and HTN into the HIV care program. Comparisons of the community HIV testing rates in the two communities, engagement in HIV care among those testing positive, and 24-month retention in HIV care will be assessed among a cohort of 107 newly enrolled patients per community.
Specifically, the aims are to determine:
- Whether integrating DM and HTN screening with HIV testing will increase the uptake of community-level HIV testing.
- If integrating DM/HTN care with HIV care enhances engagement in HIV care.
- Whether integration of DM/HTN care with HIV care enhances retention in HIV care for those newly enrolled in HIV care.
- The cost-effectiveness of integrating NCD screening and care with HIV screening and care with regard to the incremental cost per HIV infected client engaged in HIV care, and cost per newly enrolled HIV client retained in HIV care over 24-months.
- Being tested
- Blood glucose and blood pressure testing, Diet and lifestyle counseling, DM/HTN medications as needed
- Keywords
- Human Immunodeficiency Virus, Community Health Services, Chronic Disease, Integrated Delivery of Health Care, Tanzania
- Medical subject headings
- Acquired Immunodeficiency Syndrome, Diabetes Mellitus, Type 2, Hypertension, Chronic Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood glucose and blood pressure testingDiagnostic test
Also called Biosense V2 monitor, Lifesource 767 PV
Diabetes will be assessed using a 6-question risk assessment on a 10-point scale (based on a field-tested and culturally adapted International Diabetes Federation formula on DM risk factors and symptoms) and a random blood glucose test with a portable finger stick glucose monitor. Those with either: (1) a risk score of 5 or more, or (2) a random blood glucose with a value greater than 140 mg/dl, will be asked to return after fasting for at least 8 hours to have a fasting glucose test taken. Blood pressure will be assessed using a portable battery operated automatic BP cuff. The BP test will include three values taken at least 5-minutes apart and the 3 will be averaged to determine the final value.
Diet and lifestyle counselingBehavioural
All participants with elevated glucose or BP will receive personalized lifestyle counseling by trained counselors informed by lab results and that includes education on diabetes, hypertension, dietary assessment and recommendations, advice on physical activity, and the need to regularly monitor their glucose, BP, and adjust their diet, activity level, as needed. Personalized risk reduction plans will be negotiated with the client during their scheduled visits.
DM/HTN medications as neededDrug
Also called Glucophage, Metformin, Thiazide
Subjects will receive DM or HTN medications prescribed by the CTC clinician as needed.
| Study group | Role | What they receive |
|---|---|---|
| Enhanced Intervention | Experimental | Members will have DM and HTN managed at the CTC together with their HIV care. Interventions include:
1. Community mobilization activities to inform community members of available services
2. Support at the local health center to aid clinicians in managing uncontrolled cases of DM and HTN, including training for clinical staff, glucometers/test strips, and BP monitors.
3. HIV counseling and serial rapid HIV testing
4. Blood glucose and blood pressure testing
5. DM/HTN medications as needed
6. Personalized diet and lifestyle counseling for all participants with elevated glucose or BP that includes education, dietary assessment and recommendations, advice on physical activity, and the need to regularly monitor their glucose/BP. Receives: Diagnostic Test: Blood glucose and blood pressure testing; Behavioral: Diet and lifestyle counseling; Drug: DM/HTN medications as needed |
| Control | No intervention | Members in the control arm will receive community-level rapid HIV testing at the CTCs, which is the standard of care. HIV testing performed by the CTC is according to the National HIV Testing Algorithm (serial rapid testing using Determine HIV 1/2 and Uni-Gold HIV 1/2) which follows Tanzanian and international (WHO/CDC) standards for provision of HIV counseling and testing. Those who test positive for HIV will be referred to the CTC for the standard Tanzanian level of HIV care, which includes counseling and ART medication managed at the CTCs. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Uptake of community-level HIV testing
Uptake of HIV testing will be measured as the annual cumulative number of unique persons receiving HIV testing as a proportion of the community size in each HIV CTC venue using clinic records from the government CTC.
Measured: 12 months
Engagement in HIV care
Engagement will be measured as proportion of persons testing positive for HIV who advance to successful enrollment in HIV care at the CTC. Persons will be documented with biometric fingerprint matching against those who tested for HIV in the study area. Comparisons will be made across the enhanced and comparison CTCs.
Measured: 12 months
Retention in HIV care
Retention in HIV care will be measured in several ways, including the Human Resources and Services Administration HIV/AIDS Bureau definition of 2 or more outpatient visits at least 3-months apart during each year, the number of missed clinic visits, and appointment adherence (number of completed visits/number of scheduled visits) during the study period.
Measured: 24 months
Secondary outcomes (5)
Adherence to DM/HTN/ARV medication
Self-reported medication adherence questions adapted from our other NIH-funded study (Dyadic-Based Diagnosis, Care, and Prevention for HIV Discordant Couples) will be used to assess medication adherence. The Self-Reported Medication Nonadherence Measurement tool will be used to assess reasons for nonadherence.
Measured: 24 months
Adherence to physical activity intervention
Global Physical Activity Questionnaire (GPAQ) to assess DM / HTN lifestyle changes for NCD positive subjects in the intervention arm. The GPAQ is a 12-item survey created by the World Health Organization to measure physical activity (intensity, duration, and frequency) and domains of performance (related to occupation, transportation, and leisure).
Measured: 24 months
Adherence to dietary intervention
A food frequency questionnaire developed for use specifically in Tanzania and surrounding countries will be used to assess dietary changes.
Measured: 24 months
Biological, Psychological, and Social adverse events associated with the study intervention
Self-reported and staff-reported adverse events (biological, psychological, or social) experienced as an outcome of receiving the intervention.
Measured: 24 months
Cost-effectiveness of integrating NCD screening and care with HIV screening and care
Cost will be measured through regular cost worksheets that the investigators will collect throughout the duration of the study.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2017
- Study start5 Feb 2018
- Primary completion5 Aug 2022
- Study completion5 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Human Immunodeficiency VirusStudies of the same condition, open and under way.
- More trials run by Medical University of South CarolinaThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Once two similar HIV Care and Treatment Centers (CTCs) are matched, they will be randomized to receive either the intervention or control condition.
- Masking
- None (open label)
- Enrolment
- 214 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), Muhimbili University of Health and Allied Sciences
- Responsible party
- Sponsor
- Investigators
- Michael D. Sweat, PhD, Principal investigator, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03098654
- Sponsor's protocol ID
- Pro00064733
- Other IDs
- 1R01MH111366-01
- Status last verified
- Oct 2024
- First submitted
- 22 Mar 2017
- Last updated
- 30 Oct 2024
- 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 30 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Integrated HIV/NCD Screening on HIV Testing Uptake and Engagement in HIV Care: an RCT in Kisarawe, Tanzania
- ClinicalTrials.gov ID
- NCT03098654
- Acronym / sponsor ID
- Pro00064733
- Keywords
- Human Immunodeficiency Virus, Community Health Services, Chronic Disease, Integrated Delivery of Health Care, Tanzania
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 214 participants (actual)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), Muhimbili University of Health and Allied Sciences
- Study start
- 5 Feb 2018 (actual)
- Primary completion
- 5 Aug 2022 (actual)
- Study completion
- 5 Aug 2022 (actual)
- First posted
- 4 Apr 2017 (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 focuses on the integration of HIV and NCD screening and care. The investigators will conduct a randomized controlled trial examining the efficacy and cost-effectiveness of the intervention strategy in Kisarawe District, Tanzania, a rural area 40 KM southwest of Dar es Salaam. The study will match two similar HIV care and treatment centers (CTC) in the District, one of which will be randomized to receive the enhanced intervention which will integrate diabetes (DM) and hypertension (HTN) screening with the existing HIV testing program, and integrate care for DM and HTN into the HIV care program. Comparisons of the community HIV testing rates in the two communities, engagement in HIV care among those testing positive, and 24-month retention in HIV care will be assessed among a cohort of 107 newly enrolled patients per community.
Specifically, the aims are to determine:
- Whether integrating DM and HTN screening with HIV testing will increase the uptake of community-level HIV testing.
- If integrating DM/HTN care with HIV care enhances engagement in HIV care.
- Whether integration of DM/HTN care with HIV care enhances retention in HIV care for those newly enrolled in HIV care.
- The cost-effectiveness of integrating NCD screening and care with HIV screening and care with regard to the incremental cost per HIV infected client engaged in HIV care, and cost per newly enrolled HIV client retained in HIV care over 24-months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Once two similar HIV Care and Treatment Centers (CTCs) are matched, they will be randomized to receive either the intervention or control condition.
| Arm | Type | Receives |
|---|---|---|
| Enhanced Intervention | Experimental | Diagnostic Test: Blood glucose and blood pressure testing, Behavioral: Diet and lifestyle counseling, Drug: DM/HTN medications as neededMembers will have DM and HTN managed at the CTC together with their HIV care. Interventions include: 1. Community mobilization activities to inform community members of available services 2. Support at the local health center to aid clinicians in managing uncontrolled cases of DM and HTN, including training for clinical staff, glucometers/test strips, and BP monitors. 3. HIV counseling and serial rapid HIV testing 4. Blood glucose and blood pressure testing 5. DM/HTN medications as needed 6. Personalized diet and lifestyle counseling for all participants with elevated glucose or BP that includes education, dietary assessment and recommendations, advice on physical activity, and the need to regularly monitor their glucose/BP. |
| Control | No intervention | –Members in the control arm will receive community-level rapid HIV testing at the CTCs, which is the standard of care. HIV testing performed by the CTC is according to the National HIV Testing Algorithm (serial rapid testing using Determine HIV 1/2 and Uni-Gold HIV 1/2) which follows Tanzanian and international (WHO/CDC) standards for provision of HIV counseling and testing. Those who test positive for HIV will be referred to the CTC for the standard Tanzanian level of HIV care, which includes counseling and ART medication managed at the CTCs. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Be aged 18 years or above.
- Recently enrolled in HIV care and treatment
Key exclusion criteria (3 listed)
- Potentially vulnerable populations (incarcerated, under age of consent, unable to understand the procedures planned, etc.).
- Individuals under the influence of drugs or alcohol and anyone presenting with mental disability that would preclude ability to understand study procedure, risks, and benefits.
- Inability or unwillingness of subject to provide informed consent.
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 |
|---|---|---|
| Blood glucose and blood pressure testingAlso: Biosense V2 monitor, Lifesource 767 PVDiabetes will be assessed using a 6-question risk assessment on a 10-point scale (based on a field-tested and culturally adapted International Diabetes Federation formula on DM risk factors and symptoms) and a random blood glucose test with a portable finger stick glucose monitor. Those with either: (1) a risk score of 5 or more, or (2) a random blood glucose with a value greater than 140 mg/dl, will be asked to return after fasting for at least 8 hours to have a fasting glucose test taken. Blood pressure will be assessed using a portable battery operated automatic BP cuff. The BP test will include three values taken at least 5-minutes apart and the 3 will be averaged to determine the final value. | Diagnostic test | Enhanced Intervention |
| Diet and lifestyle counselingAll participants with elevated glucose or BP will receive personalized lifestyle counseling by trained counselors informed by lab results and that includes education on diabetes, hypertension, dietary assessment and recommendations, advice on physical activity, and the need to regularly monitor their glucose, BP, and adjust their diet, activity level, as needed. Personalized risk reduction plans will be negotiated with the client during their scheduled visits. | Behavioural | Enhanced Intervention |
| DM/HTN medications as neededAlso: Glucophage, Metformin, ThiazideSubjects will receive DM or HTN medications prescribed by the CTC clinician as needed. | Drug | Enhanced Intervention |
Primary outcome
Uptake of community-level HIV testing
Time frame: 12 months
Uptake of HIV testing will be measured as the annual cumulative number of unique persons receiving HIV testing as a proportion of the community size in each HIV CTC venue using clinic records from the government CTC.
Engagement in HIV care
Time frame: 12 months
Engagement will be measured as proportion of persons testing positive for HIV who advance to successful enrollment in HIV care at the CTC. Persons will be documented with biometric fingerprint matching against those who tested for HIV in the study area. Comparisons will be made across the enhanced and comparison CTCs.
Retention in HIV care
Time frame: 24 months
Retention in HIV care will be measured in several ways, including the Human Resources and Services Administration HIV/AIDS Bureau definition of 2 or more outpatient visits at least 3-months apart during each year, the number of missed clinic visits, and appointment adherence (number of completed visits/number of scheduled visits) during the study period.
5 secondary outcomes
Adherence to DM/HTN/ARV medication
Time frame: 24 months
Adherence to physical activity intervention
Time frame: 24 months
Adherence to dietary intervention
Time frame: 24 months
Biological, Psychological, and Social adverse events associated with the study intervention
Time frame: 24 months
Cost-effectiveness of integrating NCD screening and care with HIV screening and care
Time frame: 24 months
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 30 Oct 2024.
- Individual participant dataSharing planned: No
Related trials for Human Immunodeficiency Virus
Not yet recruiting
HealthMpowerment Korea: Pilot Testing the Cultural Adaptation of a Digital HIV Intervention for Men Who Have Sex With Men in South Korea
HIV Infections, HIV Prevention and Care
Not yet recruiting
Prescribe to Prevent HIV: A Hybrid Trial Helping Addiction Clinics Prevent HIV & Infections Through Safer Drug Use Support
People Who Use Opioids/People With Opioid Use Disorder (OUD)
Recruiting
Evaluating the Impact of Using the B-OK Bottles for HIV and ART Literacy in South Africa
HIV, HIV Treatment
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
RecruitingObservational study
Olfactory Function and Model-Based Behavior in People Living With HIV and SUD
HIV, Substance Use Disorder
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.
Michael D. Sweat, PhD principal investigator
Medical University of South Carolina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood glucose and blood pressure testing, Diet and lifestyle counseling and DM/HTN medications as needed in people with Human Immunodeficiency Virus and Diabetes Mellitus, Type 2, run by Medical University of South Carolina at 1 site in Tanzania.
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 2 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 30 Oct 2024. 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 Tanzania. 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?
Uptake of community-level HIV testing (time frame: 12 months). The study lists 3 primary outcomes in all. 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 30 Oct 2024.