HIVmLAKENCT02556957
CHWs, mHealth, and Combination HIV Prevention
A study testing HealthScouts in people with HIV, run by Johns Hopkins University at 1 site in Uganda.
Trial summary
Kasensero, a fishing community on Lake Victoria in Uganda, is a representative HIV "hotspot" with extremely high HIV prevalence (44.3%) and incidence (~3.9/100py), yet low HIV service utilization. Read more about this study
- Who is it for?
- Ages 15 years and olderHealthy volunteers can take part
- Conditions the study is for
- HIV
- What is being tested?
- HealthScouts
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,773 participants
- Where
- 1 siteUganda
- Study dates
- Sep 2015to Dec 2018
- 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 15 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Resident of Kasensero
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: CHWs, mHealth, and Combination HIV Prevention: An Implementation Science Cluster-Randomized Trial (mLAKE)
Kasensero, a fishing community on Lake Victoria in Uganda, is a representative HIV "hotspot" with extremely high HIV prevalence (44.3%) and incidence (~3.9/100py), yet low HIV service utilization. Hotspots such as Kasensero may seed and sustain HIV in general populations, compromising national and regional HIV control efforts. PEPFAR, UNAIDS, and WHO have recognized the urgent need to target hotspots with enhanced HIV treatment and prevention efforts. However, evidence on low-cost, comprehensive, and effective HIV control strategies for hotspots is limited and is thus a priority need for the field.
The investigators propose an implementation science, cluster-randomized, controlled trial in Kasensero to evaluate the impact on HIV service uptake and HIV incidence of CHWs promoting combination HIV prevention (CHP) services supported by mobile health technologies (mHealth). CHP is the implementation of multiple, evidence-based HIV prevention services (HIV testing and counseling, antiretroviral therapy, medical male circumcision, and behavior change) to maximize population-level impact on HIV incidence. For CHP to substantively decrease HIV incidence, most community members must be assessed for risk factors and current CHP utilization, then triaged, motivated, linked, and, if HIV-infected, retained in care. The proposed intervention will use low-cost CHWs leveraging mHealth decision support and counseling tools to promote CHP along this entire continuum of HIV service utilization. The hypotheses for this implementation science research are that residents in clusters receiving the implementation intervention will have improved CHP service uptake and decreased Population Prevalence of Viremia (PPDV) compared to controls receiving standard of care.
Read more
The intervention will be evaluated through a pragmatic, cluster-randomized trial nested within a large, ongoing population-based cohort study of HIV, the Rakai Community Cohort Study (RCCS). Intervention arm participants will be visited in their place of residence by CHWs trained to evaluate and triage participants into risk categories, provide tailored CHP health counseling, linkage, and adherence support, all supported by a mHealth decision support tool. The primary outcomes will be CHP service coverage and PPDV. Other outcomes will be HIV incidence, population viral load, implementation measures, retention, virologic suppression, and sexual behaviors.
Complimentary mixed methods (quantitative, qualitative, and cost) evaluations of the trial will be conducted to evaluate implementation processes, facilitators, and barriers to inform study results and future program uptake. Focus groups and in-depth interviews will be conducted during and after the follow-up period and synthesized with quantitative data. Intervention costs will be prospectively measured to provide information on program affordability.
Through this study, a novel, low-cost, and scalable implementation intervention to improve CHP uptake will be evaluated in an HIV "hotspot" critical to controlling the HIV epidemic. The study design ensures rigorous evidence of immediate relevance to many stakeholders.
- Conditions
- HIV
- Being tested
- HealthScouts, Standard of Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HealthScoutsBehavioural
Standard of CareOther
| Study group | Role | What they receive |
|---|---|---|
| HealthScouts Intervention | Experimental | HealthScouts (CHWs) regularly visit residents and counsel them using a motivational interviewing approach, supported by a smartphone application. Receives: Behavioral: HealthScouts; Other: Standard of Care |
| Standard of Care | Active comparator | Referral by RCCS to HIV services. Free HIV clinic available in the community. Receives: Other: Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Population Prevalence of Detectable Viremia
Proportion of the entire population who have detectable HIV viremia
Measured: 4 Years
ART Coverage (self-report)
Proportion of HIV+ persons who are on ART
Measured: 4 Years
HIV Care Coverage (self-report)
Proportion of HIV+ persons who are in HIV care
Measured: 4 years
Medical Male Circumcision Coverage (self-report)
Proportion of men who are circumcised
Measured: 4 years.
Secondary outcomes (5)
HIV Incidence
Measured: 4 years.
Sexual Behaviors (self-report)
Proportion of the population which has multiple partners and/or inconsistent or no condom use
Measured: 4 years
Population HIV Viral Load
The mean viral load of HIV+ persons
Measured: 4 years
HIV Counseling and Testing Coverage (self-report)
Proportion of the entire population who have received HIV Counseling and Testing
Measured: 4 years
HIV Prevalence
The prevalence of HIV in the entire population
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2015 (estimated)
- Study startSep 2015
- Primary completionDec 2018
- Study completionDec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HIVStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe 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
- Single blind
- Who is masked
- Investigator
- Enrolment
- 3,773 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Larry W Chang, Principal investigator, Johns Hopkins School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02556957
- Sponsor's protocol ID
- IRB00062089
- Acronym
- mLAKE
- Status last verified
- Sep 2019
- First submitted
- 20 Sep 2015
- Last updated
- 31 Aug 2020
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Chang LW, Pollard R, Mbabali I, Anok A, Hutton H, Amico KR, Kong X, Mulamba J, Ssekasanvu J, Long A, Thomas AG, Thomas K, Bugos E, van Wickle K, Kennedy CE, Nalugoda F, Beres LK, Bollinger RC, Quinn TC, Serwadda D, Gray RH, Wawer MJ, Reynolds SJ, Nakigozi G. Mixed Methods, Implementation Science Evaluation of a Community Health Worker Strategy for HIV Service Engagement in Uganda. J Acquir Immune Defic Syndr. 2023 Sep 1;94(1):28-36. doi: 10.1097/QAI.0000000000003220.
PubMed 37195924Chang LW, Mbabali I, Hutton H, Amico KR, Kong X, Mulamba J, Anok A, Ssekasanvu J, Long A, Thomas AG, Thomas K, Bugos E, Pollard R, van Wickle K, Kennedy CE, Nalugoda F, Serwadda D, Bollinger RC, Quinn TC, Reynolds SJ, Gray RH, Wawer MJ, Nakigozi G. Novel community health worker strategy for HIV service engagement in a hyperendemic community in Rakai, Uganda: A pragmatic, cluster-randomized trial. PLoS Med. 2021 Jan 6;18(1):e1003475. doi: 10.1371/journal.pmed.1003475. eCollection 2021 Jan.
PubMed 33406130Chang LW, Mbabali I, Kong X, Hutton H, Amico KR, Kennedy CE, Nalugoda F, Serwadda D, Bollinger RC, Quinn TC, Reynolds SJ, Gray R, Wawer M, Nakigozi G. Impact of a community health worker HIV treatment and prevention intervention in an HIV hotspot fishing community in Rakai, Uganda (mLAKE): study protocol for a randomized controlled trial. Trials. 2017 Oct 23;18(1):494. doi: 10.1186/s13063-017-2243-6.
PubMed 29061194
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CHWs, mHealth, and Combination HIV Prevention: An Implementation Science Cluster-Randomized Trial (mLAKE)
- ClinicalTrials.gov ID
- NCT02556957
- Acronym / sponsor ID
- mLAKE / IRB00062089
- Conditions
- HIV
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3,773 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Study start
- Sep 2015 (actual)
- Primary completion
- Dec 2018 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 22 Sep 2015 (estimated)
- 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.
Kasensero, a fishing community on Lake Victoria in Uganda, is a representative HIV "hotspot" with extremely high HIV prevalence (44.3%) and incidence (~3.9/100py), yet low HIV service utilization. Hotspots such as Kasensero may seed and sustain HIV in general populations, compromising national and regional HIV control efforts. PEPFAR, UNAIDS, and WHO have recognized the urgent need to target hotspots with enhanced HIV treatment and prevention efforts. However, evidence on low-cost, comprehensive, and effective HIV control strategies for hotspots is limited and is thus a priority need for the field.
The investigators propose an implementation science, cluster-randomized, controlled trial in Kasensero to evaluate the impact on HIV service uptake and HIV incidence of CHWs promoting combination HIV prevention (CHP) services supported by mobile health technologies (mHealth). CHP is the implementation of multiple, evidence-based HIV prevention services (HIV testing and counseling, antiretroviral therapy, medical male circumcision, and behavior change) to maximize population-level impact on HIV incidence. For CHP to substantively decrease HIV incidence, most community members must be assessed for risk factors and current CHP utilization, then triaged, motivated, linked, and, if HIV-infected, retained in care. The proposed intervention will use low-cost CHWs leveraging mHealth decision support and counseling tools to promote CHP along this entire continuum of HIV service utilization. The hypotheses for this implementation science research are that residents in clusters receiving the implementation intervention will have improved CHP service uptake and decreased Population Prevalence of Viremia (PPDV) compared to controls receiving standard of care.
The intervention will be evaluated through a pragmatic, cluster-randomized trial nested within a large, ongoing population-based cohort study of HIV, the Rakai Community Cohort Study (RCCS). Intervention arm participants will be visited in their place of residence by CHWs trained to evaluate and triage participants into risk categories, provide tailored CHP health counseling, linkage, and adherence support, all supported by a mHealth decision support tool. The primary outcomes will be CHP service coverage and PPDV. Other outcomes will be HIV incidence, population viral load, implementation measures, retention, virologic suppression, and sexual behaviors.
Complimentary mixed methods (quantitative, qualitative, and cost) evaluations of the trial will be conducted to evaluate implementation processes, facilitators, and barriers to inform study results and future program uptake. Focus groups and in-depth interviews will be conducted during and after the follow-up period and synthesized with quantitative data. Intervention costs will be prospectively measured to provide information on program affordability.
Through this study, a novel, low-cost, and scalable implementation intervention to improve CHP uptake will be evaluated in an HIV "hotspot" critical to controlling the HIV epidemic. The study design ensures rigorous evidence of immediate relevance to many stakeholders.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HealthScouts Intervention | Experimental | Behavioral: HealthScouts, Other: Standard of CareHealthScouts (CHWs) regularly visit residents and counsel them using a motivational interviewing approach, supported by a smartphone application. |
| Standard of Care | Active comparator | Other: Standard of CareReferral by RCCS to HIV services. Free HIV clinic available in the community. |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Resident of Kasensero
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| HealthScouts | Behavioural | HealthScouts Intervention |
| Standard of Care | Other | HealthScouts Intervention, Standard of Care |
Primary outcome
Population Prevalence of Detectable Viremia
Time frame: 4 Years
Proportion of the entire population who have detectable HIV viremia
ART Coverage (self-report)
Time frame: 4 Years
Proportion of HIV+ persons who are on ART
HIV Care Coverage (self-report)
Time frame: 4 years
Proportion of HIV+ persons who are in HIV care
Medical Male Circumcision Coverage (self-report)
Time frame: 4 years.
Proportion of men who are circumcised
5 secondary outcomes
HIV Incidence
Time frame: 4 years.
Sexual Behaviors (self-report)
Time frame: 4 years
Population HIV Viral Load
Time frame: 4 years
HIV Counseling and Testing Coverage (self-report)
Time frame: 4 years
HIV Prevalence
Time frame: 4 years
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 31 Aug 2020.
- Derived from this study: PubMed 37195924Chang LW, Pollard R, Mbabali I, Anok A, Hutton H, Amico KR, Kong X, Mulamba J, Ssekasanvu J, Long A, Thomas AG, Thomas K, Bugos E, van Wickle K, Kennedy CE, Nalugoda F, Beres LK, Bollinger RC, Quinn TC, Serwadda D, Gray RH, Wawer MJ, Reynolds SJ, Nakigozi G. Mixed Methods, Implementation Science Evaluation of a Community Health Worker Strategy for HIV Service Engagement in Uganda. J Acquir Immune Defic Syndr. 2023 Sep 1;94(1):28-36. doi: 10.1097/QAI.0000000000003220.
- Derived from this study: PubMed 33406130Chang LW, Mbabali I, Hutton H, Amico KR, Kong X, Mulamba J, Anok A, Ssekasanvu J, Long A, Thomas AG, Thomas K, Bugos E, Pollard R, van Wickle K, Kennedy CE, Nalugoda F, Serwadda D, Bollinger RC, Quinn TC, Reynolds SJ, Gray RH, Wawer MJ, Nakigozi G. Novel community health worker strategy for HIV service engagement in a hyperendemic community in Rakai, Uganda: A pragmatic, cluster-randomized trial. PLoS Med. 2021 Jan 6;18(1):e1003475. doi: 10.1371/journal.pmed.1003475. eCollection 2021 Jan.
- Derived from this study: PubMed 29061194Chang LW, Mbabali I, Kong X, Hutton H, Amico KR, Kennedy CE, Nalugoda F, Serwadda D, Bollinger RC, Quinn TC, Reynolds SJ, Gray R, Wawer M, Nakigozi G. Impact of a community health worker HIV treatment and prevention intervention in an HIV hotspot fishing community in Rakai, Uganda (mLAKE): study protocol for a randomized controlled trial. Trials. 2017 Oct 23;18(1):494. doi: 10.1186/s13063-017-2243-6.
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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.
Larry W Chang principal investigator
Johns Hopkins School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HealthScouts in people with HIV, run by Johns Hopkins University at 1 site in Uganda.
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 1 inclusion and 1 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 31 Aug 2020. 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 Uganda. 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?
Population Prevalence of Detectable Viremia (time frame: 4 Years). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02556957, which also lists 3 linked publications.
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 31 Aug 2020.