Clinical trial NCT04117984: Swaziland HIV Incidence Measurement Survey 2
Official title: Swaziland HIV Incidence Measurement Survey (SHIMS 2, 2016): a Population-based HIV Impact Assessment (PHIA)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV/AIDS
Keywords: Population-based survey
HIV
Antenatal care
PMTCT
Intimate Partner Violence (IPV)
Tuberculosis
Lead sponsor: Columbia University
Sponsor class: OTHER
Collaborators: name: Centers for Disease Control and Prevention
name: Ministry of Health, Swaziland
First posted: 2019-10-07
Enrollment: 15429
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
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.

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.

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.

Eligibility criteria: 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.)

Primary outcomes:
measure: HIV incident rate among adults 15 years and older
timeFrame: 1 year
measure: Sub-national prevalence of suppressed HIV viral load (<1,000 copies/mL) among adults 15 and older
timeFrame: 1 year
measure: HIV prevalence of children ages 0-14
timeFrame: 1 year
Secondary outcomes:
measure: HIV Prevalence in 2016 among adults 15 years and older
timeFrame: 1 year
measure: HIV incidence estimates among young women aged 18-24 in 2011 versus 2016
timeFrame: 1 year
measure: Incidents of HIV infection among adults from risky behaviors
timeFrame: 1 year
measure: Mean population viral load among adults living with HIV
timeFrame: 1 year
measure: Prevalence of adult viral suppression in 2011 versus 2016
timeFrame: 1 year
measure: CD4+ count distribution of adults living with HIV
timeFrame: 1 year
measure: Enrollment rate in HIV care among adults with prevalent HIV infection
timeFrame: 1 year
measure: Prevalence of antiretroviral therapy (ART) use among adults and children with prevalent HIV infection
timeFrame: 1 year
measure: Uptake of HIV testing and ART use among women recently pregnant or breastfeeding
timeFrame: 1 year
measure: Prevalence of transmitted antiretroviral (ARV) drug resistance (DR) among adults and children with recent HIV infection
timeFrame: 1 year
measure: Prevalence of viral suppression among adults and children on ART
timeFrame: 1 year
measure: Incidence of reported sexual behavior associated with HIV transmission risk among adults
timeFrame: 1 year
measure: Percentage of prior testing and knowledge of HIV status among adults
timeFrame: 1 year
measure: Prevalence of male circumcision among men 15 years and older and among male children
timeFrame: 1 year
measure: Uptake of tuberculosis services among adults
timeFrame: 1 year
measure: Acceptability rate of early ART use among adults who test HIV sero-positive and self report as not currently on ART
timeFrame: 1 year
measure: Prevalence of HIV infection among children
timeFrame: 1 year
measure: Enrollment rate in HIV care among HIV-infected children
timeFrame: 1 year
measure: CD4+ count distribution of children living with HIV
timeFrame: 1 year
measure: Prevalence of sub-national viral suppression among children living with HIV
timeFrame: 1 year
measure: Prevalence of sexual behavior and debut associated with HIV transmission risk among participants aged 10-14 years
timeFrame: 1 year
Other outcomes:
Locations:
city: Mbabane
country: Swaziland
facility: ICAP at Columbia University
Study officials:
affiliation: Columbia University
name: Jessica Justman, MD
role: STUDY_DIRECTOR
affiliation: Columbia University
name: David Hoos, MD
role: STUDY_DIRECTOR
affiliation: Columbia University
name: Harriet Nuwagaba-Biribonwoha, MD
role: PRINCIPAL_INVESTIGATOR
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