Swaziland HIV Incidence Measurement Survey 2

NCT04117984 | Completed

• 2 other identifiers: AAAQ8889U2GGH001271
• Study Type: observational
• Target: 15,429
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

HIV/AIDS

Keywords

Population-based survey; HIV; Antenatal care; PMTCT; Intimate Partner Violence (IPV); Tuberculosis

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• HIV prevalence of children ages 0-14

  A representation of the child population will be sampled

  1 year

Secondary Outcomes (21)

• HIV Prevalence in 2016 among adults 15 years and older

  1 year

• HIV incidence estimates among young women aged 18-24 in 2011 versus 2016

  1 year

• Incidents of HIV infection among adults from risky behaviors

  1 year

• Mean population viral load among adults living with HIV

  1 year

• Prevalence of adult viral suppression in 2011 versus 2016

  1 year

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

• 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.)

Sponsors & Collaborators

• Columbia University: lead
• Centers for Disease Control and Prevention: collaborator
• Ministry of Health, Swaziland: collaborator

Study Sites (1)

ICAP at Columbia University

Mbabane, Eswatini

Location

Related Publications (11)

• 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.

  PMID: 34166316 BACKGROUND

• 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.

  PMID: 34166315 BACKGROUND

• 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.

  PMID: 34166312 BACKGROUND

• 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.

  PMID: 34166307 BACKGROUND

• 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.

  PMID: 34166309 BACKGROUND

• 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.

  PMID: 33765683 BACKGROUND

• 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.

  PMID: 34166313 BACKGROUND

• 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.

  PMID: 32407305 BACKGROUND

• 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.

  PMID: 29994836 BACKGROUND

• 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.

  PMID: 29768142 BACKGROUND

• 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.

  PMID: 31092927 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

A repository of dried blood spots and plasma samples will be retained for up to 10 years.

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome; Tuberculosis

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses

Study Officials

• Jessica Justman, MD

  Columbia University

  STUDY DIRECTOR

• David Hoos, MD

  Columbia University

  STUDY DIRECTOR

• Harriet Nuwagaba-Biribonwoha, MD

  Columbia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Epidemiology

Study Record Dates

• First Submitted: October 4, 2019
• First Posted: October 7, 2019
• Study Start: August 30, 2016
• Primary Completion: December 31, 2017
• Study Completion: December 31, 2019
• Last Updated: February 9, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will share
• Time Frame: Approximately 12 months after data collection ceases.
• Access Criteria: Public release dataset.

Locations

ES (1)