- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04117984
Swaziland HIV Incidence Measurement Survey 2 (SHIMS2)
Swaziland HIV Incidence Measurement Survey (SHIMS 2, 2016): a Population-based HIV Impact Assessment (PHIA)
Study Overview
Status
Conditions
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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-
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Mbabane, Swaziland
- ICAP at Columbia University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- ADULT
- OLDER_ADULT
- CHILD
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
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
- 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
Exclusion Criteria:
- 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.)
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
HIV incident rate among adults 15 years and older
Time Frame: 1 year
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The survey will allow calculation of a national HIV incidence estimate using HIV-1 Limiting Antigen (LAg)-Avidity Enzyme Immunoassay
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1 year
|
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
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1 year
|
HIV prevalence of children ages 0-14
Time Frame: 1 year
|
A representation of the child population will be sampled
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1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
HIV Prevalence in 2016 among adults 15 years and older
Time Frame: 1 year
|
The entire adult population will be sampled
|
1 year
|
HIV incidence estimates among young women aged 18-24 in 2011 versus 2016
Time Frame: 1 year
|
The incidence estimates measured in 2016 will be compared to the previous survey incidence estimates in 2011
|
1 year
|
Incidents of HIV infection among adults from risky behaviors
Time Frame: 1 year
|
Questionnaire indicators will be used for this measure, specifically questions on sexual behavior and other risky behaviors
|
1 year
|
Mean population viral load among adults living with HIV
Time Frame: 1 year
|
Viral load of HIV-infected participants will be measured using Abbott, Roche, or a similar platform
|
1 year
|
Prevalence of adult viral suppression in 2011 versus 2016
Time Frame: 1 year
|
The viral load suppression measured in 2016 will be compared to the previous survey in 2011, national and regional
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1 year
|
CD4+ count distribution of adults living with HIV
Time Frame: 1 year
|
The total population of HIV positive adults will be sampled, national
|
1 year
|
Enrollment rate in HIV care among adults with prevalent HIV infection
Time Frame: 1 year
|
Questionnaire indicators will be used for this measure
|
1 year
|
Prevalence of antiretroviral therapy (ART) use among adults and children with prevalent HIV infection
Time Frame: 1 year
|
Questionnaire indicators will be used for this measure
|
1 year
|
Uptake of HIV testing and ART use among women recently pregnant or breastfeeding
Time Frame: 1 year
|
Questionnaire indicators will be used for this measure
|
1 year
|
Prevalence of transmitted antiretroviral (ARV) drug resistance (DR) among adults and children with recent HIV infection
Time Frame: 1 year
|
The sub population of HIV infected individuals will be sampled
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1 year
|
Prevalence of viral suppression among adults and children on ART
Time Frame: 1 year
|
Questionnaire indicators will be used for this measure
|
1 year
|
Incidence of reported sexual behavior associated with HIV transmission risk among adults
Time Frame: 1 year
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Questionnaire indicators will be used for this measure, specifically questions on sexual behavior and other risky behaviors
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1 year
|
Percentage of prior testing and knowledge of HIV status among adults
Time Frame: 1 year
|
Questionnaire indicators will be used for this measure
|
1 year
|
Prevalence of male circumcision among men 15 years and older and among male children
Time Frame: 1 year
|
Questionnaire indicators will be used for this measure
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1 year
|
Uptake of tuberculosis services among adults
Time Frame: 1 year
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Questionnaire indicators will be used for this measure
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1 year
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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
|
Questionnaire indicators will be used for this measure
|
1 year
|
Prevalence of HIV infection among children
Time Frame: 1 year
|
Questionnaire indicators will be used for this measure
|
1 year
|
Enrollment rate in HIV care among HIV-infected children
Time Frame: 1 year
|
Questionnaire indicators will be used for this measure
|
1 year
|
CD4+ count distribution of children living with HIV
Time Frame: 1 year
|
The total population of HIV positive children will be sampled, national
|
1 year
|
Prevalence of sub-national viral suppression among children living with HIV
Time Frame: 1 year
|
Viral load of HIV-infected participants will be measured using Abbott, Roche, or similar platform
|
1 year
|
Prevalence of sexual behavior and debut associated with HIV transmission risk among participants aged 10-14 years
Time Frame: 1 year
|
Questionnaire indicators will be used for this measure, specifically questions on sexual behavior and other risky behaviors
|
1 year
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Jessica Justman, MD, Columbia University
- Study Director: David Hoos, MD, Columbia University
- Principal Investigator: Harriet Nuwagaba-Biribonwoha, MD, Columbia University
Publications and helpful links
General 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, Voetsch AC. 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.
- Voetsch 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.
- Reid 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.
- Porter 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.
- Patel 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.
- Hines 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.
- Bray 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.
- Jonnalagadda 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.
- Saito 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.
- Justman 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.
- Dwyer-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.
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- RNA Virus Infections
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Sexually Transmitted Diseases, Viral
- Sexually Transmitted Diseases
- Lentivirus Infections
- Retroviridae Infections
- Immunologic Deficiency Syndromes
- Immune System Diseases
- Slow Virus Diseases
- HIV Infections
- Acquired Immunodeficiency Syndrome
Other Study ID Numbers
- AAAQ8889
- U2GGH001271 (NIH)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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