HIV/AIDSSHIMS2NCT04117984
Swaziland HIV Incidence Measurement Survey 2
An observational study of HIV/AIDS, run by Columbia University at 1 site in Eswatini.
Trial summary
The second Swaziland HIV Incidence Measurement Survey (SHIMS 2, 2016), is a population based HIV Impact Assessment (PHIA) that will assess the prevalence of key human immunodeficiency virus (HIV)-related health indicators. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- HIV/AIDS
- How many people
- 15,429 participants
- Where
- 1 siteEswatini
- Study dates
- 30 Aug 2016to 31 Dec 2019
- Phase
- Observational
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: The sampling frame will be comprised of all households in the country, based on the 2007 Population and Housing Census of Swaziland. The sampling frame consists of 2,064 EAs, containing 212,195 households and 1,005,206 persons, with an average number of 105 households per EA.
Who may be able to join
- Participants 18 Years and Older:
- Resides in selected household or spent the night before the survey there, per above definitions, and
- Self-reported age 18 years and above, and
- Ability and willingness to provide written informed consent in English or siSwati
- Participants 10-17 Years:
- Resides in selected household or spent the night before the survey there, per above definitions, and
Show all 13Show fewer
- Self-reported age 10-17 years, and
- Ability and willingness to provide written assent and parent/guardian able and willing to provide written informed consent/permission in English or siSwati, or
- For children with special circumstances 12-17 years old, ability and willingness to provide written informed consent in English or siSwati
- Participants 0-9 Years:
- Resides in selected household or spent the night before the survey there, per above definitions, and
- Parent/guardian or child with special circumstances who reports subject's age as 0-9 years, and
- Parent/guardian/child with special circumstances is able and willing to provide written, informed consent/permission in English or siSwati
Who cannot join
- Persons who are unable to give consent due to cognitive impairment or intellectual disability will not be eligible to participate. (Individuals with other disabilities who are otherwise able to give written informed consent, mark, or thumb print will be offered survey participation.)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Swaziland HIV Incidence Measurement Survey (SHIMS 2, 2016): a Population-based HIV Impact Assessment (PHIA)
The second Swaziland HIV Incidence Measurement Survey (SHIMS 2, 2016), is a population based HIV Impact Assessment (PHIA) that will assess the prevalence of key human immunodeficiency virus (HIV)-related health indicators. This is a two-stage cluster sampled cross-sectional survey of 6,417 randomly selected households in Swaziland. Approximately 20,292 eligible persons will be approached (4,664 participants 0-14 years; 12,563 participants 15-49 years; 3,065 participants 50 years and older). Of the sample approached, 15,403 are expected to agree to a blood draw for home-based HIV rapid testing including 3,361 participants 0-14 years; 9,680 participants 15-49 years; and 2,362 participants 50 years and older. SHIMS 2, 2016 will characterize HIV incidence, prevalence, viral load suppression, cluster of differentiation 4 (CD4) T-cell distribution, and risk behaviors in a household-based, nationally-representative sample of the Swazi population and will describe uptake of key HIV prevention, care, and treatment services.
Read the detailed description
After nearly three decades of Swaziland's national HIV response, a rigorous, population-based measure of the above biological endpoints will provide a valuable follow-up assessment of the impact of the national HIV program. National HIV prevalence and incidence surveys have been carried out in several countries including Uganda (2004), Tanzania (2003), Kenya (2007, 2012), and Swaziland (2011). Specifically in Swaziland, the 2011 SHIMS survey provided critical data on national-level, population-based HIV prevalence, HIV incidence, self-reported antiretroviral therapy (ART) use and viral suppression (VS) among adults 18-49 years. Importantly, SHIMS 2011 lacked data on HIV incidence among participants aged 15-17 years and adults older than 49 years, and HIV prevalence among children 0-14 years. Lack of this vital information limits effective national program planning, resource mobilization, and allocation.
SHIMS 2, 2016 will measure HIV incidence and other HIV-related measures, such as CD4 T-cell count distribution, viral load setpoint (VLS), and prevalence of ARV metabolites and transmitted HIV in Swaziland. SHIMS 2, 2016 will provide an opportunity to characterize the current status of the HIV epidemic and provide greater clarity on the impact of the national HIV program. It will provide important updated information on HIV incidence and uptake of HIV-related services that will allow for measurement of program impact and progress towards 90-90-90 targets. The survey will also estimate the prevalence and distribution of selected behaviors typically associated with HIV acquisition and transmission, for targeted programing in the continued scale-up of HIV services.
SHIMS 2, 2016 will assess the impact of the HIV control efforts in Swaziland, and inform programs moving forward to better tailor the approaches to the most impactful intervention areas and groups that need them. The data will be used to assess country specific HIV indicators, including the impact of the expansion of HIV prevention and treatment programs to facilitate effective monitoring of national HIV programs.
- Conditions
- HIV/AIDS
- Keywords
- Population-based survey, HIV, Antenatal care, PMTCT, Intimate Partner Violence (IPV), Tuberculosis
- Medical subject headings
- Acquired Immunodeficiency Syndrome, Tuberculosis
What is being measured
The primary outcome is the main question the study is designed to answer.
HIV incident rate among adults 15 years and older
The survey will allow calculation of a national HIV incidence estimate using HIV-1 Limiting Antigen (LAg)-Avidity Enzyme Immunoassay
Measured: 1 year
Sub-national prevalence of suppressed HIV viral load (<1,000 copies/mL) among adults 15 and older
Viral load (VL) (viral copies/mL) of HIV-infected participants will be measured using Abbott, Roche, or similar platform
Measured: 1 year
HIV prevalence of children ages 0-14
A representation of the child population will be sampled
Measured: 1 year
Secondary outcomes (21)
HIV Prevalence in 2016 among adults 15 years and older
The entire adult population will be sampled
Measured: 1 year
HIV incidence estimates among young women aged 18-24 in 2011 versus 2016
The incidence estimates measured in 2016 will be compared to the previous survey incidence estimates in 2011
Measured: 1 year
Incidents of HIV infection among adults from risky behaviors
Questionnaire indicators will be used for this measure, specifically questions on sexual behavior and other risky behaviors
Measured: 1 year
Mean population viral load among adults living with HIV
Viral load of HIV-infected participants will be measured using Abbott, Roche, or a similar platform
Measured: 1 year
Prevalence of adult viral suppression in 2011 versus 2016
The viral load suppression measured in 2016 will be compared to the previous survey in 2011, national and regional
Measured: 1 year
CD4+ count distribution of adults living with HIV
The total population of HIV positive adults will be sampled, national
Measured: 1 year
Enrollment rate in HIV care among adults with prevalent HIV infection
Questionnaire indicators will be used for this measure
Measured: 1 year
Prevalence of antiretroviral therapy (ART) use among adults and children with prevalent HIV infection
Questionnaire indicators will be used for this measure
Measured: 1 year
Uptake of HIV testing and ART use among women recently pregnant or breastfeeding
Questionnaire indicators will be used for this measure
Measured: 1 year
Prevalence of transmitted antiretroviral (ARV) drug resistance (DR) among adults and children with recent HIV infection
The sub population of HIV infected individuals will be sampled
Measured: 1 year
Prevalence of viral suppression among adults and children on ART
Questionnaire indicators will be used for this measure
Measured: 1 year
Incidence of reported sexual behavior associated with HIV transmission risk among adults
Questionnaire indicators will be used for this measure, specifically questions on sexual behavior and other risky behaviors
Measured: 1 year
Percentage of prior testing and knowledge of HIV status among adults
Questionnaire indicators will be used for this measure
Measured: 1 year
Prevalence of male circumcision among men 15 years and older and among male children
Questionnaire indicators will be used for this measure
Measured: 1 year
Uptake of tuberculosis services among adults
Questionnaire indicators will be used for this measure
Measured: 1 year
Acceptability rate of early ART use among adults who test HIV sero-positive and self report as not currently on ART
Questionnaire indicators will be used for this measure
Measured: 1 year
Prevalence of HIV infection among children
Questionnaire indicators will be used for this measure
Measured: 1 year
Enrollment rate in HIV care among HIV-infected children
Questionnaire indicators will be used for this measure
Measured: 1 year
CD4+ count distribution of children living with HIV
The total population of HIV positive children will be sampled, national
Measured: 1 year
Prevalence of sub-national viral suppression among children living with HIV
Viral load of HIV-infected participants will be measured using Abbott, Roche, or similar platform
Measured: 1 year
Prevalence of sexual behavior and debut associated with HIV transmission risk among participants aged 10-14 years
Questionnaire indicators will be used for this measure, specifically questions on sexual behavior and other risky behaviors
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2019
- Study start30 Aug 2016
- Primary completion31 Dec 2017
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for HIV/AIDSStudies of the same condition, open and under way.
- More trials run by Columbia 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
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 15,429 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Collaborators
- Centers for Disease Control and Prevention, Ministry of Health, Swaziland
- Responsible party
- Principal investigator, Harriet Nuwagaba-Biribonwoha, Columbia University
- Investigators
- Jessica Justman, MD, Study director, Columbia UniversityDavid Hoos, MD, Study director, Columbia UniversityHarriet Nuwagaba-Biribonwoha, MD, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04117984
- Sponsor's protocol ID
- AAAQ8889
- Other IDs
- U2GGH001271
- Acronym
- SHIMS2
- Status last verified
- Feb 2023
- First submitted
- 4 Oct 2019
- Last updated
- 9 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be anonymised, and will be part of a public release dataset released approximately 12 months after data collection ceases via a SHIMS website.
Publications
West CA, Chang GC, W Currie D, Bray R, Kinchen S, Behel S, McCullough-Sanden R, Low A, Bissek A, Shang JD, Ndongmo CB, Dokubo EK, Balachandra S, Lobognon LR, Dube L, Nuwagaba-Biribonwoha H, Li M, Pasipamire M, Getaneh Y, Lulseged S, Eshetu F, Kingwara L, Zielinski-Gutierrez E, Tlhomola M, Ramphalla P, Kalua T, F Auld A, B Williams D, Remera E, Rwibasira GN, Mugisha V, Malamba SS, Mushi J, Jalloh MF, Mgomella GS, Kirungi WL, Biraro S, C Awor A, Barradas DT, Mugurungi O, H Rogers J, Bronson M, M Bodika S, Ajiboye A, Gaffga N, Moore C, Patel HK, C Voetsch A. Unawareness of HIV Infection Among Men Aged 15-59 Years in 13 Sub-Saharan African Countries: Findings From the Population-Based HIV Impact Assessments, 2015-2019. J Acquir Immune Defic Syndr. 2021 Aug 1;87(Suppl 1):S97-S106. doi: 10.1097/QAI.0000000000002708.
PubMed 34166316Voetsch AC, Duong YT, Stupp P, Saito S, McCracken S, Dobbs T, Winterhalter FS, Williams DB, Mengistu A, Mugurungi O, Chikwanda P, Musuka G, Ndongmo CB, Dlamini S, Nuwagaba-Biribonwoha H, Pasipamire M, Tegbaru B, Eshetu F, Biraro S, Ward J, Aibo D, Kabala A, Mgomella GS, Malewo O, Mushi J, Payne D, Mengistu Y, Asiimwe F, Shang JD, Dokubo EK, Eno LT, Zoung-Kanyi Bissek AC, Kingwara L, Junghae M, Kiiru JN, Mwesigwa RCN, Balachandra S, Lobognon R, Kampira E, Detorio M, Yufenyuy EL, Brown K, Patel HK, Parekh BS. HIV-1 Recent Infection Testing Algorithm With Antiretroviral Drug Detection to Improve Accuracy of Incidence Estimates. J Acquir Immune Defic Syndr. 2021 Aug 1;87(Suppl 1):S73-S80. doi: 10.1097/QAI.0000000000002707.
PubMed 34166315Reid G, Voetsch AC, Stupp P, McCracken S, Kalton G, Dlamini S, McOllogi Juma J, Kalua T, Kirungi W, Koto M, Mugurungi O, Mulenga L, Mutenda N, Marum L, Saito S. Improving Sampling Efficiency for Determining Pediatric HIV Prevalence in National Surveys: Evidence From 8 Sub-Saharan African Countries. J Acquir Immune Defic Syndr. 2021 Aug 1;87(Suppl 1):S43-S51. doi: 10.1097/QAI.0000000000002704.
PubMed 34166312Porter L, Bello G, Nkambule R, Justman J. HIV General Population Surveys: Shedding Light on the Status of HIV Epidemics and Informing Future Actions. J Acquir Immune Defic Syndr. 2021 Aug 1;87(Suppl 1):S2-S5. doi: 10.1097/QAI.0000000000002701.
PubMed 34166307Patel HK, Duong YT, Birhanu S, Dobbs T, Lupoli K, Moore C, Detorio M, Sleeman K, Manjengwa J, Wray-Gordon F, Yavo D, Jackson K, Domaoal RA, Yufenyuy EL, Vedapuri S, Ndongmo CB, Ogollah FM, Dzinamarira T, Rubinstein P, Sachathep KK, Metz M, Longwe H, Saito S, Brown K, Voetsch AC, Parekh BS. A Comprehensive Approach to Assuring Quality of Laboratory Testing in HIV Surveys: Lessons Learned From the Population-Based HIV Impact Assessment Project. J Acquir Immune Defic Syndr. 2021 Aug 1;87(Suppl 1):S17-S27. doi: 10.1097/QAI.0000000000002702.
PubMed 34166309Hines JZ, Sachathep K, Pals S, Davis SM, Toledo C, Bronson M, Parekh B, Carrasco M, Xaba S, Mandisarisa J, Kamobyi R, Chituwo O, Kirungi WL, Alamo S, Kabuye G, Awor AC, Mmbando S, Simbeye D, Aupokolo MA, Zemburuka B, Nyirenda R, Msungama W, Tarumbiswa T, Manda R, Nuwagaba-Biribonwoha H, Kiggundu V, Thomas AG, Watts H, Voetsch AC, Williams DB. HIV Incidence by Male Circumcision Status From the Population-Based HIV Impact Assessment Surveys-Eight Sub-Saharan African Countries, 2015-2017. J Acquir Immune Defic Syndr. 2021 Aug 1;87(Suppl 1):S89-S96. doi: 10.1097/QAI.0000000000002658.
PubMed 33765683Bray R, Palma AM, Philip NM, Brown K, Levin B, Thompson JLPS, Ginindza C, Mulenga LB. Is Interview Length Associated With Blood Test Participation? Evidence From Three Population-Based HIV Impact Assessment Surveys Conducted From 2016 to 2017. J Acquir Immune Defic Syndr. 2021 Aug 1;87(Suppl 1):S57-S66. doi: 10.1097/QAI.0000000000002705.
PubMed 34166313Jonnalagadda S, Yuengling K, Abrams E, Stupp P, Voetsch A, Patel M, Minisi Z, Eliya M, Hamunime N, Rwebembera A, Kirungi W, Mulenga L, Mushavi A, Ryan C, Ts'oeu M, Kim E, Dziuban EJ, Hageman K, Galbraith J, Mweebo K, Mwila A, Gonese E, Patel H, Modi S, Saito S. Survival and HIV-Free Survival Among Children Aged </=3 Years - Eight Sub-Saharan African Countries, 2015-2017. MMWR Morb Mortal Wkly Rep. 2020 May 15;69(19):582-586. doi: 10.15585/mmwr.mm6919a3.
PubMed 32407305Saito S, Chung H, Mahy M, Radin AK, Jonnalagadda S, Hakim A, Awor AC, Mwila A, Gonese E, Wadonda-Kabondo N, Rwehumbiza P, Ao T, Kim EJ, Frederix K, Nuwagaba-Biribonwoha H, Musuka G, Mugurungi O, Mushii J, Mnisi Z, Munthali G, Jahn A, Kirungi WL, Sivile S, Abrams EJ. Pediatric HIV Treatment Gaps in 7 East and Southern African Countries: Examination of Modeled, Survey, and Routine Program Data. J Acquir Immune Defic Syndr. 2018 Aug 15;78 Suppl 2:S134-S141. doi: 10.1097/QAI.0000000000001739.
PubMed 29994836Justman JE, Mugurungi O, El-Sadr WM. HIV Population Surveys - Bringing Precision to the Global Response. N Engl J Med. 2018 May 17;378(20):1859-1861. doi: 10.1056/NEJMp1801934. No abstract available.
PubMed 29768142Dwyer-Lindgren L, Cork MA, Sligar A, Steuben KM, Wilson KF, Provost NR, Mayala BK, VanderHeide JD, Collison ML, Hall JB, Biehl MH, Carter A, Frank T, Douwes-Schultz D, Burstein R, Casey DC, Deshpande A, Earl L, El Bcheraoui C, Farag TH, Henry NJ, Kinyoki D, Marczak LB, Nixon MR, Osgood-Zimmerman A, Pigott D, Reiner RC Jr, Ross JM, Schaeffer LE, Smith DL, Davis Weaver N, Wiens KE, Eaton JW, Justman JE, Opio A, Sartorius B, Tanser F, Wabiri N, Piot P, Murray CJL, Hay SI. Mapping HIV prevalence in sub-Saharan Africa between 2000 and 2017. Nature. 2019 Jun;570(7760):189-193. doi: 10.1038/s41586-019-1200-9. Epub 2019 May 15.
PubMed 31092927
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Swaziland HIV Incidence Measurement Survey (SHIMS 2, 2016): a Population-based HIV Impact Assessment (PHIA)
- ClinicalTrials.gov ID
- NCT04117984
- Acronym / sponsor ID
- SHIMS2 / AAAQ8889
- Conditions
- HIV/AIDS
- Keywords
- Population-based survey, HIV, Antenatal care, PMTCT, Intimate Partner Violence (IPV), Tuberculosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 15,429 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- Centers for Disease Control and Prevention, Ministry of Health, Swaziland
- Study start
- 30 Aug 2016 (actual)
- Primary completion
- 31 Dec 2017 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 7 Oct 2019 (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.
The second Swaziland HIV Incidence Measurement Survey (SHIMS 2, 2016), is a population based HIV Impact Assessment (PHIA) that will assess the prevalence of key human immunodeficiency virus (HIV)-related health indicators. This is a two-stage cluster sampled cross-sectional survey of 6,417 randomly selected households in Swaziland. Approximately 20,292 eligible persons will be approached (4,664 participants 0-14 years; 12,563 participants 15-49 years; 3,065 participants 50 years and older). Of the sample approached, 15,403 are expected to agree to a blood draw for home-based HIV rapid testing including 3,361 participants 0-14 years; 9,680 participants 15-49 years; and 2,362 participants 50 years and older. SHIMS 2, 2016 will characterize HIV incidence, prevalence, viral load suppression, cluster of differentiation 4 (CD4) T-cell distribution, and risk behaviors in a household-based, nationally-representative sample of the Swazi population and will describe uptake of key HIV prevention, care, and treatment services.
Detailed description
After nearly three decades of Swaziland's national HIV response, a rigorous, population-based measure of the above biological endpoints will provide a valuable follow-up assessment of the impact of the national HIV program. National HIV prevalence and incidence surveys have been carried out in several countries including Uganda (2004), Tanzania (2003), Kenya (2007, 2012), and Swaziland (2011). Specifically in Swaziland, the 2011 SHIMS survey provided critical data on national-level, population-based HIV prevalence, HIV incidence, self-reported antiretroviral therapy (ART) use and viral suppression (VS) among adults 18-49 years. Importantly, SHIMS 2011 lacked data on HIV incidence among participants aged 15-17 years and adults older than 49 years, and HIV prevalence among children 0-14 years. Lack of this vital information limits effective national program planning, resource mobilization, and allocation.
SHIMS 2, 2016 will measure HIV incidence and other HIV-related measures, such as CD4 T-cell count distribution, viral load setpoint (VLS), and prevalence of ARV metabolites and transmitted HIV in Swaziland. SHIMS 2, 2016 will provide an opportunity to characterize the current status of the HIV epidemic and provide greater clarity on the impact of the national HIV program. It will provide important updated information on HIV incidence and uptake of HIV-related services that will allow for measurement of program impact and progress towards 90-90-90 targets. The survey will also estimate the prevalence and distribution of selected behaviors typically associated with HIV acquisition and transmission, for targeted programing in the continued scale-up of HIV services.
SHIMS 2, 2016 will assess the impact of the HIV control efforts in Swaziland, and inform programs moving forward to better tailor the approaches to the most impactful intervention areas and groups that need them. The data will be used to assess country specific HIV indicators, including the impact of the expansion of HIV prevention and treatment programs to facilitate effective monitoring of national HIV programs.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The sampling frame will be comprised of all households in the country, based on the 2007 Population and Housing Census of Swaziland. The sampling frame consists of 2,064 EAs, containing 212,195 households and 1,005,206 persons, with an average number of 105 households per EA.
Key inclusion criteria (13 listed)
- Resides in selected household or spent the night before the survey there, per above definitions, and
- Self-reported age 18 years and above, and
- Ability and willingness to provide written informed consent in English or siSwati
- Resides in selected household or spent the night before the survey there, per above definitions, and
- Self-reported age 10-17 years, and
Key exclusion criteria (1 listed)
- Persons who are unable to give consent due to cognitive impairment or intellectual disability will not be eligible to participate. (Individuals with other disabilities who are otherwise able to give written informed consent, mark, or thumb print will be offered survey participation.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
HIV incident rate among adults 15 years and older
Time frame: 1 year
The survey will allow calculation of a national HIV incidence estimate using HIV-1 Limiting Antigen (LAg)-Avidity Enzyme Immunoassay
Sub-national prevalence of suppressed HIV viral load (<1,000 copies/mL) among adults 15 and older
Time frame: 1 year
Viral load (VL) (viral copies/mL) of HIV-infected participants will be measured using Abbott, Roche, or similar platform
HIV prevalence of children ages 0-14
Time frame: 1 year
A representation of the child population will be sampled
21 secondary outcomes
HIV Prevalence in 2016 among adults 15 years and older
Time frame: 1 year
HIV incidence estimates among young women aged 18-24 in 2011 versus 2016
Time frame: 1 year
Incidents of HIV infection among adults from risky behaviors
Time frame: 1 year
Mean population viral load among adults living with HIV
Time frame: 1 year
Prevalence of adult viral suppression in 2011 versus 2016
Time frame: 1 year
CD4+ count distribution of adults living with HIV
Time frame: 1 year
Enrollment rate in HIV care among adults with prevalent HIV infection
Time frame: 1 year
Prevalence of antiretroviral therapy (ART) use among adults and children with prevalent HIV infection
Time frame: 1 year
Uptake of HIV testing and ART use among women recently pregnant or breastfeeding
Time frame: 1 year
Prevalence of transmitted antiretroviral (ARV) drug resistance (DR) among adults and children with recent HIV infection
Time frame: 1 year
Prevalence of viral suppression among adults and children on ART
Time frame: 1 year
Incidence of reported sexual behavior associated with HIV transmission risk among adults
Time frame: 1 year
Percentage of prior testing and knowledge of HIV status among adults
Time frame: 1 year
Prevalence of male circumcision among men 15 years and older and among male children
Time frame: 1 year
Uptake of tuberculosis services among adults
Time frame: 1 year
Acceptability rate of early ART use among adults who test HIV sero-positive and self report as not currently on ART
Time frame: 1 year
Prevalence of HIV infection among children
Time frame: 1 year
Enrollment rate in HIV care among HIV-infected children
Time frame: 1 year
CD4+ count distribution of children living with HIV
Time frame: 1 year
Prevalence of sub-national viral suppression among children living with HIV
Time frame: 1 year
Prevalence of sexual behavior and debut associated with HIV transmission risk among participants aged 10-14 years
Time frame: 1 year
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 9 Feb 2023.
- Background: PubMed 34166316West CA, Chang GC, W Currie D, Bray R, Kinchen S, Behel S, McCullough-Sanden R, Low A, Bissek A, Shang JD, Ndongmo CB, Dokubo EK, Balachandra S, Lobognon LR, Dube L, Nuwagaba-Biribonwoha H, Li M, Pasipamire M, Getaneh Y, Lulseged S, Eshetu F, Kingwara L, Zielinski-Gutierrez E, Tlhomola M, Ramphalla P, Kalua T, F Auld A, B Williams D, Remera E, Rwibasira GN, Mugisha V, Malamba SS, Mushi J, Jalloh MF, Mgomella GS, Kirungi WL, Biraro S, C Awor A, Barradas DT, Mugurungi O, H Rogers J, Bronson M, M Bodika S, Ajiboye A, Gaffga N, Moore C, Patel HK, C Voetsch A. Unawareness of HIV Infection Among Men Aged 15-59 Years in 13 Sub-Saharan African Countries: Findings From the Population-Based HIV Impact Assessments, 2015-2019. J Acquir Immune Defic Syndr. 2021 Aug 1;87(Suppl 1):S97-S106. doi: 10.1097/QAI.0000000000002708.
- Background: PubMed 34166315Voetsch AC, Duong YT, Stupp P, Saito S, McCracken S, Dobbs T, Winterhalter FS, Williams DB, Mengistu A, Mugurungi O, Chikwanda P, Musuka G, Ndongmo CB, Dlamini S, Nuwagaba-Biribonwoha H, Pasipamire M, Tegbaru B, Eshetu F, Biraro S, Ward J, Aibo D, Kabala A, Mgomella GS, Malewo O, Mushi J, Payne D, Mengistu Y, Asiimwe F, Shang JD, Dokubo EK, Eno LT, Zoung-Kanyi Bissek AC, Kingwara L, Junghae M, Kiiru JN, Mwesigwa RCN, Balachandra S, Lobognon R, Kampira E, Detorio M, Yufenyuy EL, Brown K, Patel HK, Parekh BS. HIV-1 Recent Infection Testing Algorithm With Antiretroviral Drug Detection to Improve Accuracy of Incidence Estimates. J Acquir Immune Defic Syndr. 2021 Aug 1;87(Suppl 1):S73-S80. doi: 10.1097/QAI.0000000000002707.
- Background: PubMed 34166312Reid G, Voetsch AC, Stupp P, McCracken S, Kalton G, Dlamini S, McOllogi Juma J, Kalua T, Kirungi W, Koto M, Mugurungi O, Mulenga L, Mutenda N, Marum L, Saito S. Improving Sampling Efficiency for Determining Pediatric HIV Prevalence in National Surveys: Evidence From 8 Sub-Saharan African Countries. J Acquir Immune Defic Syndr. 2021 Aug 1;87(Suppl 1):S43-S51. doi: 10.1097/QAI.0000000000002704.
- Background: PubMed 34166307Porter L, Bello G, Nkambule R, Justman J. HIV General Population Surveys: Shedding Light on the Status of HIV Epidemics and Informing Future Actions. J Acquir Immune Defic Syndr. 2021 Aug 1;87(Suppl 1):S2-S5. doi: 10.1097/QAI.0000000000002701.
- Background: PubMed 34166309Patel HK, Duong YT, Birhanu S, Dobbs T, Lupoli K, Moore C, Detorio M, Sleeman K, Manjengwa J, Wray-Gordon F, Yavo D, Jackson K, Domaoal RA, Yufenyuy EL, Vedapuri S, Ndongmo CB, Ogollah FM, Dzinamarira T, Rubinstein P, Sachathep KK, Metz M, Longwe H, Saito S, Brown K, Voetsch AC, Parekh BS. A Comprehensive Approach to Assuring Quality of Laboratory Testing in HIV Surveys: Lessons Learned From the Population-Based HIV Impact Assessment Project. J Acquir Immune Defic Syndr. 2021 Aug 1;87(Suppl 1):S17-S27. doi: 10.1097/QAI.0000000000002702.
- Background: PubMed 33765683Hines JZ, Sachathep K, Pals S, Davis SM, Toledo C, Bronson M, Parekh B, Carrasco M, Xaba S, Mandisarisa J, Kamobyi R, Chituwo O, Kirungi WL, Alamo S, Kabuye G, Awor AC, Mmbando S, Simbeye D, Aupokolo MA, Zemburuka B, Nyirenda R, Msungama W, Tarumbiswa T, Manda R, Nuwagaba-Biribonwoha H, Kiggundu V, Thomas AG, Watts H, Voetsch AC, Williams DB. HIV Incidence by Male Circumcision Status From the Population-Based HIV Impact Assessment Surveys-Eight Sub-Saharan African Countries, 2015-2017. J Acquir Immune Defic Syndr. 2021 Aug 1;87(Suppl 1):S89-S96. doi: 10.1097/QAI.0000000000002658.
- Background: PubMed 34166313Bray R, Palma AM, Philip NM, Brown K, Levin B, Thompson JLPS, Ginindza C, Mulenga LB. Is Interview Length Associated With Blood Test Participation? Evidence From Three Population-Based HIV Impact Assessment Surveys Conducted From 2016 to 2017. J Acquir Immune Defic Syndr. 2021 Aug 1;87(Suppl 1):S57-S66. doi: 10.1097/QAI.0000000000002705.
- Background: PubMed 32407305Jonnalagadda S, Yuengling K, Abrams E, Stupp P, Voetsch A, Patel M, Minisi Z, Eliya M, Hamunime N, Rwebembera A, Kirungi W, Mulenga L, Mushavi A, Ryan C, Ts'oeu M, Kim E, Dziuban EJ, Hageman K, Galbraith J, Mweebo K, Mwila A, Gonese E, Patel H, Modi S, Saito S. Survival and HIV-Free Survival Among Children Aged </=3 Years - Eight Sub-Saharan African Countries, 2015-2017. MMWR Morb Mortal Wkly Rep. 2020 May 15;69(19):582-586. doi: 10.15585/mmwr.mm6919a3.
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- Individual participant dataSharing planned: Yes. Data will be anonymised, and will be part of a public release dataset released approximately 12 months after data collection ceases via a SHIMS website.
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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.
Jessica Justman, MD study director
Columbia University
David Hoos, MD study director
Columbia University
Harriet Nuwagaba-Biribonwoha, MD principal investigator
Columbia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV/AIDS, run by Columbia University at 1 site in Eswatini.
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 13 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 9 Feb 2023. 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 Eswatini. 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?
HIV incident rate among adults 15 years and older (time frame: 1 year). 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?
On the ClinicalTrials.gov record for NCT04117984, which also lists 11 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 9 Feb 2023.