ICAP at Columbia University
Mbabane, Eswatini
NCT Number: NCT04117984
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.
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Observational
Mbabane, Eswatini
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Participants 18 Years and Older:
Participants 10-17 Years:
Participants 0-9 Years:
Exclusion criteria
Time frame: 1 year
The survey will allow calculation of a national HIV incidence estimate using HIV-1 Limiting Antigen (LAg)-Avidity Enzyme Immunoassay
Time frame: 1 year
Viral load (VL) (viral copies/mL) of HIV-infected participants will be measured using Abbott, Roche, or similar platform
Time frame: 1 year
A representation of the child population will be sampled
Time frame: 1 year
The entire adult population will be sampled
Time frame: 1 year
The incidence estimates measured in 2016 will be compared to the previous survey incidence estimates in 2011
Time frame: 1 year
Questionnaire indicators will be used for this measure, specifically questions on sexual behavior and other risky behaviors
Time frame: 1 year
Viral load of HIV-infected participants will be measured using Abbott, Roche, or a similar platform
Time frame: 1 year
The viral load suppression measured in 2016 will be compared to the previous survey in 2011, national and regional
Time frame: 1 year
The total population of HIV positive adults will be sampled, national
Time frame: 1 year
Questionnaire indicators will be used for this measure
Time frame: 1 year
Questionnaire indicators will be used for this measure
Time frame: 1 year
Questionnaire indicators will be used for this measure
Time frame: 1 year
The sub population of HIV infected individuals will be sampled
Time frame: 1 year
Questionnaire indicators will be used for this measure
Time frame: 1 year
Questionnaire indicators will be used for this measure, specifically questions on sexual behavior and other risky behaviors
Time frame: 1 year
Questionnaire indicators will be used for this measure
Time frame: 1 year
Questionnaire indicators will be used for this measure
Time frame: 1 year
Questionnaire indicators will be used for this measure
Time frame: 1 year
Questionnaire indicators will be used for this measure
Time frame: 1 year
Questionnaire indicators will be used for this measure
Time frame: 1 year
Questionnaire indicators will be used for this measure
Time frame: 1 year
The total population of HIV positive children will be sampled, national
Time frame: 1 year
Viral load of HIV-infected participants will be measured using Abbott, Roche, or similar platform
Time frame: 1 year
Questionnaire indicators will be used for this measure, specifically questions on sexual behavior and other risky behaviors
Columbia University
Other
Swaziland HIV Incidence Measurement Survey (SHIMS 2, 2016): a Population-based HIV Impact Assessment (PHIA)
Acronym: SHIMS2
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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