Swaziland HIV Incidence Measurement Survey 2 (SHIMS2)

Columbia University

Status: Completed

Conditions: HIV/AIDS

Study type: Observational

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT04117984

U2GGH001271 (U.S. NIH Grant/Contract)

AAAQ8889

Details and patient eligibility

About

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.

Full 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.

Enrollment: 15,429 patients

Sex: All

Volunteers: Accepts Healthy Volunteers

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.)