Human Immunodeficiency VirusNCT04772469
Self-Test Strategies and Linkage Incentives to Improve ART and PrEP Uptake in Men
A study testing Provision of multiple self-tests, Small monetary incentives and Use of SMS/text reminders to motivate adherence to ART or PrEP in people with Human Immunodeficiency Virus and Acquired Immunodeficiency Syndrome, run by University of California, San Francisco at 1 site in Kenya.
Trial summary
This is a randomized controlled trial to test a combination behavioral and biomedical interventions to improve the HIV prevention and care cascades in a population of mobile men in a high priority setting (fishermen in Kenya). Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Human Immunodeficiency Virus, Acquired Immunodeficiency Syndrome, HIV Infections
- What is being tested?
- Provision of multiple self-tests, Small monetary incentives and Use of SMS/text reminders to motivate adherence to ART or PrEP
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 934 participants
- Where
- 1 siteKenya
- Study dates
- 22 Mar 2021to 26 Apr 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult (18 years or older)
- Male
- Working as a fisherman or fishing-related occupation
- Willing and able to provide informed consent for participation
- Not participating in another research study related to HIV testing, treatment and/or prevention
Who cannot join
- Younger than 18 years of age
- Female
- Included in another intervention study on HIV/AIDS
- Inadequate cognitive and/or hearing capacity to complete planned study procedures, at the discretion of the study team
Trial locations and contacts
1 site in 1 country.
About this study
This is a randomized controlled trial to test a combination behavioral and biomedical interventions to improve the HIV prevention and care cascades in a population of mobile men in a high priority setting (fishermen in Kenya). The intervention strategy is to recruit and train highly socially-connected men to distribute HIV self-tests and provide linkage support to men in their close social networks. The study will determine whether this social network-based approach along with small financial incentives in the form of transport vouchers can increase men's self-testing, linkage to and uptake of ART and PrEP after self-testing, virologic suppression at 6 months (for those initiating ART) and PrEP adherence (for those initiating PrEP) at 6 months. The study includes a longitudinal qualitative and mixed methods (quantitative and qualitative assessments) to identify the pathways of intervention action, and understand how the social network-based approach with support for linkage affects testing and ART and PrEP uptake and retention in men.
Read the detailed description
In Aim 1, following the study pilot, community selection, and preparation the investigators will conduct a census/BMU registry verification in study communities to identify the population of men eligible for the study. The study will screen, recruit and enroll eligible men who give their informed consent to participate, then measure their close social networks identify network-central, highly-connected men ("promoters") and randomize their close social network (a cluster) to 1:1 intervention and control groups. Investigators will then conduct a baseline survey to collect socio demographic and baseline sexual behavior data among men in the close social networks. Following this baseline data collection, all promoters will be provided a training. Promoters in the intervention group will receive HIVST training, multiple HIVST for distribution to other men, and a small amount of remuneration. Promoters in the control group will receive basic HIV education and training about the study, and will be given vouchers that can be exchanged for HIV tests (standard or free HIVST kits) at nearby health facilities. Using follow-up survey data, investigators will test the hypothesis that a higher rate of HIV testing will be observed after 3 months among men in networks that receive the intervention compared to control.
In Aim 2, investigators will test whether network-central promoters can enhance linkage to ART and PrEP after HIV testing among men in their close social networks. Promoters in the Aim 1 intervention group will be asked to distribute information and transport vouchers for ART or PrEP when distributing HIV self-tests to men in their close social networks. Investigators will use clinic data to test the primary hypothesis that the intervention will result in higher rates of linkage to ART or PrEP (confirmatory testing and ART referral for positives, and PrEP screening for negatives). Investigators also will test the hypothesis that higher ART and PrEP uptake will be observed within 3 months (+ about one month) in the intervention group.
In Aim 3, investigators will measure 6 month VL and 6 month tenofovir levels using viral load testing and a novel point of care PrEP adherence assay (an antibody-based assay permitting measurement of tenofovir levels in urine) in study sites, and test the hypothesis that higher rates of virologic suppression will be observed in HIV-infected men, and PrEP adherence in un-infected men, in the intervention group. Viral load measurements will be conducted by drawing additional venous blood during routine blood draws scheduled for MOH viral load monitoring (as well as additional draws during scheduled appointments for those occurring outside of the annual VL testing standard of care window). PrEP adherence will be measured utilizing the study urine assay at 6 months. HIV treatment adherence will measured through adherence assessment during 3 and 6 routine clinic visits.
Across all aims, investigators will assess the pathways of intervention action using qualitative and mixed methods. Investigators will identify the mechanisms of action, and barriers and facilitators of the social network and incentives intervention implementation, using qualitative and mixed methods quantitative and qualitative assessments embedded in Aims 1, 2 and 3. The data collection approach will include in-depth interviews with participants in both groups, key informant interviews with network-central promoters, and focus group discussions with study participants stratified by HIV status and study group. Data will be collected at baseline and three follow-up periods corresponding to the timing of quantitative outcome measurements in Aims 1 through 3.
- Conditions
- Human Immunodeficiency Virus, Acquired Immunodeficiency Syndrome, HIV Infections, Sexually Transmitted Diseases, Viral, Retroviridae Infections, Virus Diseases
- Being tested
- Provision of multiple self-tests, Small monetary incentives, Use of SMS/text reminders to motivate adherence to ART or PrEP
- Keywords
- HIV/AIDS, Social Networks, Behavioral Economics, Incentives, PrEP, HIV Self-Testing, Fishermen, Sub Saharan Africa, Men, HIV Prevention
- Medical subject headings
- Acquired Immunodeficiency Syndrome, HIV Infections, Sexually Transmitted Diseases, Viral, Retroviridae Infections, Virus Diseases, RNA Virus Infections, Multiple Endocrine Neoplasia Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Provision of multiple self-testsBehavioural
Participants will be given multiple Oraquick Advance HIV-1/2 test kits for testing themselves more frequently and for men in their social networks.
Small monetary incentivesOther
Use of small incentive voucher (~$5) to encourage linkage to confirmatory testing.
Use of SMS/text reminders to motivate adherence to ART or PrEPBehavioural
Messages will be motivational, will not include any identifying information and will include generic texts such as "maintain your good health", to cater for status-neutral language that can work for both HIV positive individuals taking ARVs, as well as HIV-negative individuals on PrEP who may need adherence support.
| Study group | Role | What they receive |
|---|---|---|
| Promoter training, multiple self-test kits, and incentives | Experimental | Promoters in the intervention group will receive HIVST training, multiple HIVST for distribution to other men, and a small amount of remuneration (transport voucher) for themselves and to distribute to men in their networks. Receives: Behavioral: Provision of multiple self-tests; Other: Small monetary incentives; Behavioral: Use of SMS/text reminders to motivate adherence to ART or PrEP |
| Short training and referral for testing | No intervention | Promoters in the control group will a short training on the basics of HIV prevention and treatment and will be encouraged to refer men in their networks for standard of care testing at the local health facilities- this may include HIV testing with a counselor or HIV self-test from the local health clinic, depending on what is available. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-reported HIV Testing
Percentage of participants who self-report HIV testing (yes/no) within the past 3 months, measured at 3-month follow-up.
Measured: Up to 3 months
Percentage of Participants Who Linked to a Study-affiliated Clinic Within 3 Months
The percentage of participants who attended a study-affiliated clinic for HIV treatment or care within 3 months of the intervention baseline
Measured: Up to 3 months
Secondary outcomes (3)
Linkage to PrEP
Percentage of PrEP-eligible HIV-negative participants who initiate PrEP prescription (yes/no), 3-months following confirmatory testing and eligibility screening (combined)
Measured: Up to 3 months
Adherence to PrEP (% With Detectable Tenofovir in the Urine)
PrEP: Percentage of PrEP-taking HIV-negative participants who are adherent to PrEP (TFV levels of >= 1500 ng/mL) at 6 months following PrEP initiation.
Measured: Up to 6 months
Adherence to ART
ART: Percentage of HIV-positive participants who attain viral suppression (HIV RNA <400 c/mL), 6 months following ART initiation.
Measured: Up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2021
- Study start22 Mar 2021
- Primary completion26 Apr 2023
- Study completion26 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (130)Papers the sponsor has linked to this study.
- Other trials for Human Immunodeficiency VirusStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study design is a cluster randomized controlled trial where the unit of randomization will be a clusters of men's close social network in study communities.
- Masking
- None (open label)
- Enrolment
- 934 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- University of Pennsylvania, Impact Research & Development Organization, National Institute of Mental Health (NIMH), Duke University, Kenya Medical Research Institute
- Responsible party
- Sponsor
- Investigators
- Carol S Camlin, MPH, PhD, Principal investigator, University of California, San FranciscoHarsha Thirumurthy, PhD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04772469
- Sponsor's protocol ID
- 19-28205
- Other IDs
- 1R01MH120176
- Status last verified
- Apr 2025
- First submitted
- 23 Feb 2021
- Last updated
- 29 Apr 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
UNAIDS. 90-90-90: An ambitious treatment target to help end the AIDS epidemic. Geneva: UNAIDS;2014
UNAIDS. THE GAP REPORT. Geneva, Switzerland 2014.
Kwena ZA, Njuguna SW, Ssetala A, Seeley J, Nielsen L, De Bont J, Bukusi EA; Lake Victoria Consortium for Health Research (LVCHR) Team. HIV prevalence, spatial distribution and risk factors for HIV infection in the Kenyan fishing communities of Lake Victoria. PLoS One. 2019 Mar 25;14(3):e0214360. doi: 10.1371/journal.pone.0214360. eCollection 2019.
PubMed 30908555Maman D, Zeh C, Mukui I, Kirubi B, Masson S, Opolo V, Szumilin E, Riche B, Etard JF. Cascade of HIV care and population viral suppression in a high-burden region of Kenya. AIDS. 2015 Jul 31;29(12):1557-65. doi: 10.1097/QAD.0000000000000741.
PubMed 26244395NACC-NASCOP. Kenya AIDS epidemic update 2011. Nairobi, Kenya: NACC-NASCOP;2012.
Odongo SF, Kwaro D, Mutai K. Are fisherfolk at higher risk than their neighbors: Findings from western Kenya, 2015. CROI; March 4-7, 2018; Boston, Massachusetts.
Hoshi T, Fuji Y, Nzou SM, Tanigawa C, Kiche I, Mwau M, Mwangi AW, Karama M, Hirayama K, Goto K, Kaneko S. Spatial Distributions of HIV Infection in an Endemic Area of Western Kenya: Guiding Information for Localized HIV Control and Prevention. PLoS One. 2016 Feb 10;11(2):e0148636. doi: 10.1371/journal.pone.0148636. eCollection 2016.
PubMed 26862764Kiwanuka N, Ssetaala A, Nalutaaya A, Mpendo J, Wambuzi M, Nanvubya A, Sigirenda S, Kitandwe PK, Nielsen LE, Balyegisawa A, Kaleebu P, Nalusiba J, Sewankambo NK. High incidence of HIV-1 infection in a general population of fishing communities around Lake Victoria, Uganda. PLoS One. 2014 May 27;9(5):e94932. doi: 10.1371/journal.pone.0094932. eCollection 2014.
PubMed 24866840Asiki G, Mpendo J, Abaasa A, Agaba C, Nanvubya A, Nielsen L, Seeley J, Kaleebu P, Grosskurth H, Kamali A. HIV and syphilis prevalence and associated risk factors among fishing communities of Lake Victoria, Uganda. Sex Transm Infect. 2011 Oct;87(6):511-5. doi: 10.1136/sti.2010.046805. Epub 2011 Aug 10.
PubMed 21835763Cassels S, Camlin CS. Geographical mobility and heterogeneity of the HIV epidemic. Lancet HIV. 2016 Aug;3(8):e339-e341. doi: 10.1016/S2352-3018(16)30048-0. Epub 2016 Jul 9. No abstract available.
PubMed 27470023Kwena ZA, Bukusi EA, Ng'ayo MO, Buffardi AL, Nguti R, Richardson B, Sang NM, Holmes K. Prevalence and risk factors for sexually transmitted infections in a high-risk occupational group: the case of fishermen along Lake Victoria in Kisumu, Kenya. Int J STD AIDS. 2010 Oct;21(10):708-13. doi: 10.1258/ijsa.2010.010160.
PubMed 21139150Camlin CS, Kwena ZA, Dworkin SL. Jaboya vs. jakambi: Status, negotiation, and HIV risks among female migrants in the "sex for fish" economy in Nyanza Province, Kenya. AIDS Educ Prev. 2013 Jun;25(3):216-31. doi: 10.1521/aeap.2013.25.3.216.
PubMed 23631716Camlin CS, Kwena ZA, Dworkin SL, Cohen CR, Bukusi EA. "She mixes her business": HIV transmission and acquisition risks among female migrants in western Kenya. Soc Sci Med. 2014 Feb;102:146-56. doi: 10.1016/j.socscimed.2013.11.004. Epub 2013 Nov 15.
PubMed 24565152Fiorella KJ, Camlin CS, Salmen CR, et al. Transactional Fish-for-Sex Relationships Amid Declining Fish Access in Kenya. World Development. 2015;74:323-332.
Kwena ZA, Camlin CS, Shisanya CA, Mwanzo I, Bukusi EA. Short-term mobility and the risk of HIV infection among married couples in the fishing communities along Lake Victoria, Kenya. PLoS One. 2013;8(1):e54523. doi: 10.1371/journal.pone.0054523. Epub 2013 Jan 15.
PubMed 23336005
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Self-Test Strategies and Linkage Incentives to Improve ART and PrEP Uptake in Men
- ClinicalTrials.gov ID
- NCT04772469
- Acronym / sponsor ID
- 19-28205
- Conditions
- Human Immunodeficiency Virus, Acquired Immunodeficiency Syndrome, HIV Infections, Sexually Transmitted Diseases, Viral, Retroviridae Infections, Virus Diseases
- Keywords
- HIV/AIDS, Social Networks, Behavioral Economics, Incentives, PrEP, HIV Self-Testing, Fishermen, Sub Saharan Africa
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 934 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- University of Pennsylvania, Impact Research & Development Organization, National Institute of Mental Health (NIMH), Duke University, Kenya Medical Research Institute
- Study start
- 22 Mar 2021 (actual)
- Primary completion
- 26 Apr 2023 (actual)
- Study completion
- 26 Apr 2023 (actual)
- First posted
- 26 Feb 2021 (actual)
- Results
- Posted 29 Apr 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a randomized controlled trial to test a combination behavioral and biomedical interventions to improve the HIV prevention and care cascades in a population of mobile men in a high priority setting (fishermen in Kenya). The intervention strategy is to recruit and train highly socially-connected men to distribute HIV self-tests and provide linkage support to men in their close social networks. The study will determine whether this social network-based approach along with small financial incentives in the form of transport vouchers can increase men's self-testing, linkage to and uptake of ART and PrEP after self-testing, virologic suppression at 6 months (for those initiating ART) and PrEP adherence (for those initiating PrEP) at 6 months. The study includes a longitudinal qualitative and mixed methods (quantitative and qualitative assessments) to identify the pathways of intervention action, and understand how the social network-based approach with support for linkage affects testing and ART and PrEP uptake and retention in men.
Detailed description
In Aim 1, following the study pilot, community selection, and preparation the investigators will conduct a census/BMU registry verification in study communities to identify the population of men eligible for the study. The study will screen, recruit and enroll eligible men who give their informed consent to participate, then measure their close social networks identify network-central, highly-connected men ("promoters") and randomize their close social network (a cluster) to 1:1 intervention and control groups. Investigators will then conduct a baseline survey to collect socio demographic and baseline sexual behavior data among men in the close social networks. Following this baseline data collection, all promoters will be provided a training. Promoters in the intervention group will receive HIVST training, multiple HIVST for distribution to other men, and a small amount of remuneration. Promoters in the control group will receive basic HIV education and training about the study, and will be given vouchers that can be exchanged for HIV tests (standard or free HIVST kits) at nearby health facilities. Using follow-up survey data, investigators will test the hypothesis that a higher rate of HIV testing will be observed after 3 months among men in networks that receive the intervention compared to control.
In Aim 2, investigators will test whether network-central promoters can enhance linkage to ART and PrEP after HIV testing among men in their close social networks. Promoters in the Aim 1 intervention group will be asked to distribute information and transport vouchers for ART or PrEP when distributing HIV self-tests to men in their close social networks. Investigators will use clinic data to test the primary hypothesis that the intervention will result in higher rates of linkage to ART or PrEP (confirmatory testing and ART referral for positives, and PrEP screening for negatives). Investigators also will test the hypothesis that higher ART and PrEP uptake will be observed within 3 months (+ about one month) in the intervention group.
In Aim 3, investigators will measure 6 month VL and 6 month tenofovir levels using viral load testing and a novel point of care PrEP adherence assay (an antibody-based assay permitting measurement of tenofovir levels in urine) in study sites, and test the hypothesis that higher rates of virologic suppression will be observed in HIV-infected men, and PrEP adherence in un-infected men, in the intervention group. Viral load measurements will be conducted by drawing additional venous blood during routine blood draws scheduled for MOH viral load monitoring (as well as additional draws during scheduled appointments for those occurring outside of the annual VL testing standard of care window). PrEP adherence will be measured utilizing the study urine assay at 6 months. HIV treatment adherence will measured through adherence assessment during 3 and 6 routine clinic visits.
Across all aims, investigators will assess the pathways of intervention action using qualitative and mixed methods. Investigators will identify the mechanisms of action, and barriers and facilitators of the social network and incentives intervention implementation, using qualitative and mixed methods quantitative and qualitative assessments embedded in Aims 1, 2 and 3. The data collection approach will include in-depth interviews with participants in both groups, key informant interviews with network-central promoters, and focus group discussions with study participants stratified by HIV status and study group. Data will be collected at baseline and three follow-up periods corresponding to the timing of quantitative outcome measurements in Aims 1 through 3.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The study design is a cluster randomized controlled trial where the unit of randomization will be a clusters of men's close social network in study communities.
| Arm | Type | Receives |
|---|---|---|
| Promoter training, multiple self-test kits, and incentives | Experimental | Behavioral: Provision of multiple self-tests, Other: Small monetary incentives, Behavioral: Use of SMS/text reminders to motivate adherence to ART or PrEPPromoters in the intervention group will receive HIVST training, multiple HIVST for distribution to other men, and a small amount of remuneration (transport voucher) for themselves and to distribute to men in their networks. |
| Short training and referral for testing | No intervention | –Promoters in the control group will a short training on the basics of HIV prevention and treatment and will be encouraged to refer men in their networks for standard of care testing at the local health facilities- this may include HIV testing with a counselor or HIV self-test from the local health clinic, depending on what is available. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adult (18 years or older)
- Male
- Working as a fisherman or fishing-related occupation
- Willing and able to provide informed consent for participation
- Not participating in another research study related to HIV testing, treatment and/or prevention
Key exclusion criteria (4 listed)
- Younger than 18 years of age
- Female
- Included in another intervention study on HIV/AIDS
- Inadequate cognitive and/or hearing capacity to complete planned study procedures, at the discretion of the study team
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 |
|---|---|---|
| Provision of multiple self-testsParticipants will be given multiple Oraquick Advance HIV-1/2 test kits for testing themselves more frequently and for men in their social networks. | Behavioural | Promoter training, multiple self-test kits, and incentives |
| Small monetary incentivesUse of small incentive voucher (~$5) to encourage linkage to confirmatory testing. | Other | Promoter training, multiple self-test kits, and incentives |
| Use of SMS/text reminders to motivate adherence to ART or PrEPMessages will be motivational, will not include any identifying information and will include generic texts such as "maintain your good health", to cater for status-neutral language that can work for both HIV positive individuals taking ARVs, as well as HIV-negative individuals on PrEP who may need adherence support. | Behavioural | Promoter training, multiple self-test kits, and incentives |
Primary outcome
Self-reported HIV Testing
Time frame: Up to 3 months
Percentage of participants who self-report HIV testing (yes/no) within the past 3 months, measured at 3-month follow-up.
Percentage of Participants Who Linked to a Study-affiliated Clinic Within 3 Months
Time frame: Up to 3 months
The percentage of participants who attended a study-affiliated clinic for HIV treatment or care within 3 months of the intervention baseline
3 secondary outcomes
Linkage to PrEP
Time frame: Up to 3 months
Adherence to PrEP (% With Detectable Tenofovir in the Urine)
Time frame: Up to 6 months
Adherence to ART
Time frame: Up to 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- BackgroundUNAIDS. 90-90-90: An ambitious treatment target to help end the AIDS epidemic. Geneva: UNAIDS;2014
- BackgroundUNAIDS. THE GAP REPORT. Geneva, Switzerland 2014.
- Background: PubMed 30908555Kwena ZA, Njuguna SW, Ssetala A, Seeley J, Nielsen L, De Bont J, Bukusi EA; Lake Victoria Consortium for Health Research (LVCHR) Team. HIV prevalence, spatial distribution and risk factors for HIV infection in the Kenyan fishing communities of Lake Victoria. PLoS One. 2019 Mar 25;14(3):e0214360. doi: 10.1371/journal.pone.0214360. eCollection 2019.
- Background: PubMed 26244395Maman D, Zeh C, Mukui I, Kirubi B, Masson S, Opolo V, Szumilin E, Riche B, Etard JF. Cascade of HIV care and population viral suppression in a high-burden region of Kenya. AIDS. 2015 Jul 31;29(12):1557-65. doi: 10.1097/QAD.0000000000000741.
- BackgroundNACC-NASCOP. Kenya AIDS epidemic update 2011. Nairobi, Kenya: NACC-NASCOP;2012.
- BackgroundOdongo SF, Kwaro D, Mutai K. Are fisherfolk at higher risk than their neighbors: Findings from western Kenya, 2015. CROI; March 4-7, 2018; Boston, Massachusetts.
- Background: PubMed 26862764Hoshi T, Fuji Y, Nzou SM, Tanigawa C, Kiche I, Mwau M, Mwangi AW, Karama M, Hirayama K, Goto K, Kaneko S. Spatial Distributions of HIV Infection in an Endemic Area of Western Kenya: Guiding Information for Localized HIV Control and Prevention. PLoS One. 2016 Feb 10;11(2):e0148636. doi: 10.1371/journal.pone.0148636. eCollection 2016.
- Background: PubMed 24866840Kiwanuka N, Ssetaala A, Nalutaaya A, Mpendo J, Wambuzi M, Nanvubya A, Sigirenda S, Kitandwe PK, Nielsen LE, Balyegisawa A, Kaleebu P, Nalusiba J, Sewankambo NK. High incidence of HIV-1 infection in a general population of fishing communities around Lake Victoria, Uganda. PLoS One. 2014 May 27;9(5):e94932. doi: 10.1371/journal.pone.0094932. eCollection 2014.
- Background: PubMed 21835763Asiki G, Mpendo J, Abaasa A, Agaba C, Nanvubya A, Nielsen L, Seeley J, Kaleebu P, Grosskurth H, Kamali A. HIV and syphilis prevalence and associated risk factors among fishing communities of Lake Victoria, Uganda. Sex Transm Infect. 2011 Oct;87(6):511-5. doi: 10.1136/sti.2010.046805. Epub 2011 Aug 10.
- Background: PubMed 27470023Cassels S, Camlin CS. Geographical mobility and heterogeneity of the HIV epidemic. Lancet HIV. 2016 Aug;3(8):e339-e341. doi: 10.1016/S2352-3018(16)30048-0. Epub 2016 Jul 9. No abstract available.
- Background: PubMed 21139150Kwena ZA, Bukusi EA, Ng'ayo MO, Buffardi AL, Nguti R, Richardson B, Sang NM, Holmes K. Prevalence and risk factors for sexually transmitted infections in a high-risk occupational group: the case of fishermen along Lake Victoria in Kisumu, Kenya. Int J STD AIDS. 2010 Oct;21(10):708-13. doi: 10.1258/ijsa.2010.010160.
- Background: PubMed 23631716Camlin CS, Kwena ZA, Dworkin SL. Jaboya vs. jakambi: Status, negotiation, and HIV risks among female migrants in the "sex for fish" economy in Nyanza Province, Kenya. AIDS Educ Prev. 2013 Jun;25(3):216-31. doi: 10.1521/aeap.2013.25.3.216.
- 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.
Carol S Camlin, MPH, PhD principal investigator
University of California, San Francisco
Harsha Thirumurthy, PhD principal investigator
University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Provision of multiple self-tests, Small monetary incentives and Use of SMS/text reminders to motivate adherence to ART or PrEP in people with Human Immunodeficiency Virus and Acquired Immunodeficiency Syndrome, run by University of California, San Francisco at 1 site in Kenya.
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 5 inclusion and 4 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 29 Apr 2025. 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 Kenya. 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?
Yes. Results are posted in the registry (first posted 29 Apr 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Self-reported HIV Testing (time frame: Up to 3 months). The study lists 2 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 NCT04772469, which also lists 130 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 29 Apr 2025.