Swaziland HIV Incidence Measurement Survey 2

HIV/AIDS Clinical Trial

— SHIMS2  

Official title:

Swaziland HIV Incidence Measurement Survey (SHIMS 2, 2016): a Population-based HIV Impact Assessment (PHIA)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04117984
• Other study ID #: AAAQ8889
• Secondary ID: U2GGH001271
• Status: Completed
• Start date: August 30, 2016
• Est. completion date: December 31, 2019

Study information

• Verified date: February 2023
• Source: Columbia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15429
• Est. completion date: December 31, 2019
• Est. primary completion date: December 31, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

Participants 18 Years and Older:

1. Resides in selected household or spent the night before the survey there, per above definitions, and

2. Self-reported age 18 years and above, and

3. Ability and willingness to provide written informed consent in English or siSwati

Participants 10-17 Years:

1. Resides in selected household or spent the night before the survey there, per above definitions, and

2. Self-reported age 10-17 years, and

3. Ability and willingness to provide written assent and parent/guardian able and willing to provide written informed consent/permission in English or siSwati, or

4. 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:

1. Resides in selected household or spent the night before the survey there, per above definitions, and

2. Parent/guardian or child with special circumstances who reports subject's age as 0-9 years, and

3. 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.)

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV Infections
• HIV/AIDS

Locations

Country	Name	City	State
Swaziland	ICAP at Columbia University	Mbabane

Sponsors (3)

Lead Sponsor	Collaborator
Columbia University	Centers for Disease Control and Prevention, Ministry of Health, Swaziland

Country where clinical trial is conducted

Swaziland, 

References & Publications (11)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	1 year
Primary	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	1 year
Primary	HIV prevalence of children ages 0-14	A representation of the child population will be sampled	1 year
Secondary	HIV Prevalence in 2016 among adults 15 years and older	The entire adult population will be sampled	1 year
Secondary	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	1 year
Secondary	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	1 year
Secondary	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	1 year
Secondary	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	1 year
Secondary	CD4+ count distribution of adults living with HIV	The total population of HIV positive adults will be sampled, national	1 year
Secondary	Enrollment rate in HIV care among adults with prevalent HIV infection	Questionnaire indicators will be used for this measure	1 year
Secondary	Prevalence of antiretroviral therapy (ART) use among adults and children with prevalent HIV infection	Questionnaire indicators will be used for this measure	1 year
Secondary	Uptake of HIV testing and ART use among women recently pregnant or breastfeeding	Questionnaire indicators will be used for this measure	1 year
Secondary	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	1 year
Secondary	Prevalence of viral suppression among adults and children on ART	Questionnaire indicators will be used for this measure	1 year
Secondary	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	1 year
Secondary	Percentage of prior testing and knowledge of HIV status among adults	Questionnaire indicators will be used for this measure	1 year
Secondary	Prevalence of male circumcision among men 15 years and older and among male children	Questionnaire indicators will be used for this measure	1 year
Secondary	Uptake of tuberculosis services among adults	Questionnaire indicators will be used for this measure	1 year
Secondary	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	1 year
Secondary	Prevalence of HIV infection among children	Questionnaire indicators will be used for this measure	1 year
Secondary	Enrollment rate in HIV care among HIV-infected children	Questionnaire indicators will be used for this measure	1 year
Secondary	CD4+ count distribution of children living with HIV	The total population of HIV positive children will be sampled, national	1 year
Secondary	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	1 year
Secondary	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	1 year