Swaziland HIV Incidence Measurement Survey 2

Completed

• Conditions: HIV/AIDS

• Registration Number: NCT04117984
• Lead Sponsor: Columbia University

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2016-08-30
• Primary Completion: 2017-12-31
• Study First Submitted: 2019-10-04
• Study First Submitted QC: 2019-10-04
• Study First Posted: 2019-10-07
• Study Completion: 2019-12-31
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-07
• Last Update Posted: 2023-02-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15429

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

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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.)

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
HIV incident rate among adults 15 years and older	1 year	The survey will allow calculation of a national HIV incidence estimate using HIV-1 Limiting Antigen (LAg)-Avidity Enzyme Immunoassay
Sub-national prevalence of suppressed HIV viral load (<1,000 copies/mL) among adults 15 and older	1 year	Viral load (VL) (viral copies/mL) of HIV-infected participants will be measured using Abbott, Roche, or similar platform
HIV prevalence of children ages 0-14	1 year	A representation of the child population will be sampled

Secondary Outcome Measures

Name	Time	Method
Enrollment rate in HIV care among adults with prevalent HIV infection	1 year	Questionnaire indicators will be used for this measure
CD4+ count distribution of children living with HIV	1 year	The total population of HIV positive children will be sampled, national
HIV incidence estimates among young women aged 18-24 in 2011 versus 2016	1 year	The incidence estimates measured in 2016 will be compared to the previous survey incidence estimates in 2011
Uptake of HIV testing and ART use among women recently pregnant or breastfeeding	1 year	Questionnaire indicators will be used for this measure
Prevalence of transmitted antiretroviral (ARV) drug resistance (DR) among adults and children with recent HIV infection	1 year	The sub population of HIV infected individuals will be sampled
Mean population viral load among adults living with HIV	1 year	Viral load of HIV-infected participants will be measured using Abbott, Roche, or a similar platform
Acceptability rate of early ART use among adults who test HIV sero-positive and self report as not currently on ART	1 year	Questionnaire indicators will be used for this measure
Incidents of HIV infection among adults from risky behaviors	1 year	Questionnaire indicators will be used for this measure, specifically questions on sexual behavior and other risky behaviors
CD4+ count distribution of adults living with HIV	1 year	The total population of HIV positive adults will be sampled, national
Incidence of reported sexual behavior associated with HIV transmission risk among adults	1 year	Questionnaire indicators will be used for this measure, specifically questions on sexual behavior and other risky behaviors
Percentage of prior testing and knowledge of HIV status among adults	1 year	Questionnaire indicators will be used for this measure
Uptake of tuberculosis services among adults	1 year	Questionnaire indicators will be used for this measure
Prevalence of HIV infection among children	1 year	Questionnaire indicators will be used for this measure
Enrollment rate in HIV care among HIV-infected children	1 year	Questionnaire indicators will be used for this measure
Prevalence of sexual behavior and debut associated with HIV transmission risk among participants aged 10-14 years	1 year	Questionnaire indicators will be used for this measure, specifically questions on sexual behavior and other risky behaviors
Prevalence of adult viral suppression in 2011 versus 2016	1 year	The viral load suppression measured in 2016 will be compared to the previous survey in 2011, national and regional
Prevalence of antiretroviral therapy (ART) use among adults and children with prevalent HIV infection	1 year	Questionnaire indicators will be used for this measure
Prevalence of male circumcision among men 15 years and older and among male children	1 year	Questionnaire indicators will be used for this measure
Prevalence of sub-national viral suppression among children living with HIV	1 year	Viral load of HIV-infected participants will be measured using Abbott, Roche, or similar platform
HIV Prevalence in 2016 among adults 15 years and older	1 year	The entire adult population will be sampled
Prevalence of viral suppression among adults and children on ART	1 year	Questionnaire indicators will be used for this measure

Trial Locations

Locations (1)

ICAP at Columbia University; 🇸🇿 Mbabane, Swaziland