CompletedNot Applicable

Swaziland HIV Incidence Measurement Survey 2

Eswatini15,429 participantsStarted 2016-08-30

Plain-language 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.

Who can participate

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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
. 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
. Resides in selected household or spent the night before the survey there, per above definitions, and

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

HIV incident rate among adults 15 years and older

Timeframe: 1 year

Sub-national prevalence of suppressed HIV viral load (<1,000 copies/mL) among adults 15 and older

Timeframe: 1 year

HIV prevalence of children ages 0-14

Timeframe: 1 year

Trial details

NCT IDNCT04117984

SponsorColumbia University

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2017-12-31

View on ClinicalTrials.gov More HIV/AIDS trials

Plain-language summary

Who can participate

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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
. 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
. Resides in selected household or spent the night before the survey there, per above definitions, and