HIVNCT02038582
Strategies to Increase HIV Testing, Linkages to Care, and Male Circumcision in Africa
A study testing POC CD4 Testing, CD4 Referral and Lay Counselor Follow-up in people with HIV, run by University of Washington at 2 sites in 2 countries.
Trial summary
The purpose of this study is to determine efficient, scalable, evidence-based strategies to link HIV positive individuals to care and HIV negative individuals to prevention measures, such as voluntary male circumcision. Read more about this study
- Who is it for?
- Ages 16 years and olderHealthy volunteers can take part
- Conditions the study is for
- HIV
- What is being tested?
- POC CD4 Testing, CD4 Referral and Lay Counselor Follow-up
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,075 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Jun 2013to Feb 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Reside in the study community
- Must be 16 years or older
- Able and willing to provide informed consent/assent for study procedures
- HIV negative uncircumcised men must be age 16 - 49 years and have access to secure text messaging to be randomized to strategies for male circumcision.
Who cannot join
- N/A
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
South Africa1 site
Human Sciences Research Council (HSRC)
Sweetwaters, KwaZulu-Natal
Uganda1 site
Intergrated Community Based Initivatives (ICOBI)
Kabwohe, Bushenyi
About this study
Official title: An Evaluation of Strategies to Increase Testing and Linkages of HIV Positive Individuals to Care and HIV Negative Men to Male Circumcision in Sub-Saharan Africa
The purpose of this study is to determine efficient, scalable, evidence-based strategies to link HIV positive individuals to care and HIV negative individuals to prevention measures, such as voluntary male circumcision.
Read the detailed description
New strategies for HIV testing and linkages to care are needed, since only a minority of African adults have been tested in many settings and a drop-off occurs at each step from HIV and CD4 testing, remaining in pre-ART (antiretroviral therapy) care, ART initiation, and adherence over the long term.
This study aims to determine the effects of Point-of-Care (POC) CD4 testing, POC viral load (VL) testing and several linkage strategies (lay-counselor follow-up, accompaniment to HIV clinic by lay counselor, or clinical referral) on linkage to care and treatment adherence for HIV positive persons.
This study also aims to determine the uptake of voluntary circumcision among HIV uninfected males with either promotion at point of HIV testing, Short Message Service (SMS) follow-up or lay counselor follow-up visits.
- Conditions
- HIV
- Being tested
- POC CD4 Testing, CD4 Referral, Lay Counselor Follow-up, Clinic Accompaniment, Clinic Referral
- Keywords
- HIV, HIV Counseling and Testing, Linkages to Care, Point of Care CD4, Point of Care Viral Load
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
POC CD4 TestingOther
Point of Care CD4 testing
CD4 ReferralOther
Referral to CD4 testing
Lay Counselor Follow-upBehavioural
Follow-up from a lay counselor
Clinic AccompanimentBehavioural
Accompaniment to the clinic by a counselor
Clinic ReferralBehavioural
Referral to clinic
SMS ReminderBehavioural
SMS reminder for male circumcision
Circumcision PromotionBehavioural
Promotion of male circumcision at the time of HIV testing
POC VLOther
POC VL testing for HIV infected persons on ART
Laboratory based VL assayOther
Laboratory based viral load testing for HIV infected persons on ART
| Study group | Role | What they receive |
|---|---|---|
| POC CD4 & Clinic Accompaniment | Active comparator | HIV positive persons not on ART at enrollment, randomized to POC CD4 testing and follow up with clinic accompaniment Receives: Other: POC CD4 Testing; Behavioral: Clinic Accompaniment |
| POC CD4 & Lay Counselor | Active comparator | HIV positive persons not on ART at enrollment, randomized to POC CD4 testing and lay counselor follow up Receives: Other: POC CD4 Testing; Behavioral: Lay Counselor Follow-up |
| POC CD4 & Clinic Referral | Active comparator | HIV positive persons not on ART at enrollment, randomized to POC CD4 testing and referral to clinic Receives: Other: POC CD4 Testing; Behavioral: Clinic Referral |
| CD4 Referral & Clinic Accompaniment | Active comparator | HIV positive persons not on ART at enrollment, randomized to referral for CD4 testing and follow up with clinic accompaniment Receives: Other: CD4 Referral; Behavioral: Clinic Accompaniment |
| CD4 Referral & Lay Counselor | Active comparator | HIV positive persons not on ART at enrollment, randomized to referral for CD4 testing and lay counselor follow up Receives: Other: CD4 Referral; Behavioral: Lay Counselor Follow-up |
| CD4 Referral & Clinic Referral | Active comparator | HIV positive persons not on ART at enrollment, randomized to referral for CD4 testing and referral to clinic Receives: Other: CD4 Referral; Behavioral: Clinic Referral |
| Circumcision - SMS Reminder | Active comparator | HIV negative uncircumcised males, randomized to SMS reminder for male circumcision Receives: Behavioral: SMS Reminder |
| Circumcision - Lay Counselor | Active comparator | HIV negative uncircumcised males, randomized to lay counselor follow-up for male circumcision Receives: Behavioral: Lay Counselor Follow-up |
| Circumcision - Promotion | Active comparator | HIV negative uncircumcised males, randomized to promotion of male circumcision at the time of HIV testing Receives: Behavioral: Circumcision Promotion |
| POC VL | Active comparator | HIV positive persons on ART, randomized to POC viral load testing Receives: Other: POC VL |
| Laboratory based VL assay | Active comparator | HIV positive persons on ART, randomized to laboratory based viral load testing Receives: Other: Laboratory based VL assay |
What is being measured
The primary outcome is the main question the study is designed to answer.
Linkage to care for HIV infected persons not on treatment following a point-of care CD4 count compared to referral to clinic for CD4 testing
Proportion of HIV positive individuals in the POC CD4 arm who visit a clinic, obtain a staging CD4 test, initiate ART if eligible, or have a viral load <50 copies/mL within 9 months compared to those in the clinic referral arm.
Measured: Up to 12 Months
Uptake of male circumcision referral among HIV-uninfected men with either promotion at point of HIV testing, SMS follow-up or lay-counselor follow-up visits
Proportion of HIV-uninfected men who visit a male circumcision clinic or outreach venue for information about circumcision and proportion who report being circumcised by month 3 and 9 in the lay-counselor arm compared to the SMS follow-up arm, and male circumcision promotion at HIV testing arm
Measured: Up to 9 months
Linkage to care for HIV infected persons after lay counselor follow-up, accompaniment to HIV clinic by lay counselor, or clinic referral
Proportion of HIV positive individuals not on ART at baseline who visit a clinic, obtain a staging CD4 test, initiate ART if eligible, or have a viral load <50 copies/mL within 9 months in the lay counselor follow-up arm compared to the accompaniment and clinic referral arms
Measured: Up to 12 months
Secondary outcomes (1)
POC viral load testing impact on ART adherence and viral suppression compared to standard laboratory testing
Proportion of HIV positive persons with viral load <50 copies/mL at 3 months among those who receive POC viral load testing compared to those participants who receive standard laboratory-based viral load testing.
Measured: Up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2014 (estimated)
- Study startJun 2013
- Primary completionFeb 2015
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIVStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2,075 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Connie Celum, University of Washington
- Investigators
- Connie Celum, MD, MPH, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02038582
- Sponsor's protocol ID
- 44549-A
- Status last verified
- May 2015
- First submitted
- 18 Dec 2013
- Last updated
- 2 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Barnabas RV, van Rooyen H, Tumwesigye E, Brantley J, Baeten JM, van Heerden A, Turyamureeba B, Joseph P, Krows M, Thomas KK, Schaafsma TT, Hughes JP, Celum C. Uptake of antiretroviral therapy and male circumcision after community-based HIV testing and strategies for linkage to care versus standard clinic referral: a multisite, open-label, randomised controlled trial in South Africa and Uganda. Lancet HIV. 2016 May;3(5):e212-20. doi: 10.1016/S2352-3018(16)00020-5. Epub 2016 Mar 10.
PubMed 27126488
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Evaluation of Strategies to Increase Testing and Linkages of HIV Positive Individuals to Care and HIV Negative Men to Male Circumcision in Sub-Saharan Africa
- ClinicalTrials.gov ID
- NCT02038582
- Acronym / sponsor ID
- 44549-A
- Conditions
- HIV
- Keywords
- HIV, HIV Counseling and Testing, Linkages to Care, Point of Care CD4, Point of Care Viral Load
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,075 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Study start
- Jun 2013
- Primary completion
- Feb 2015 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 16 Jan 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine efficient, scalable, evidence-based strategies to link HIV positive individuals to care and HIV negative individuals to prevention measures, such as voluntary male circumcision.
Detailed description
New strategies for HIV testing and linkages to care are needed, since only a minority of African adults have been tested in many settings and a drop-off occurs at each step from HIV and CD4 testing, remaining in pre-ART (antiretroviral therapy) care, ART initiation, and adherence over the long term.
This study aims to determine the effects of Point-of-Care (POC) CD4 testing, POC viral load (VL) testing and several linkage strategies (lay-counselor follow-up, accompaniment to HIV clinic by lay counselor, or clinical referral) on linkage to care and treatment adherence for HIV positive persons.
This study also aims to determine the uptake of voluntary circumcision among HIV uninfected males with either promotion at point of HIV testing, Short Message Service (SMS) follow-up or lay counselor follow-up visits.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 11
| Arm | Type | Receives |
|---|---|---|
| POC CD4 & Clinic Accompaniment | Active comparator | Other: POC CD4 Testing, Behavioral: Clinic AccompanimentHIV positive persons not on ART at enrollment, randomized to POC CD4 testing and follow up with clinic accompaniment |
| POC CD4 & Lay Counselor | Active comparator | Other: POC CD4 Testing, Behavioral: Lay Counselor Follow-upHIV positive persons not on ART at enrollment, randomized to POC CD4 testing and lay counselor follow up |
| POC CD4 & Clinic Referral | Active comparator | Other: POC CD4 Testing, Behavioral: Clinic ReferralHIV positive persons not on ART at enrollment, randomized to POC CD4 testing and referral to clinic |
| CD4 Referral & Clinic Accompaniment | Active comparator | Other: CD4 Referral, Behavioral: Clinic AccompanimentHIV positive persons not on ART at enrollment, randomized to referral for CD4 testing and follow up with clinic accompaniment |
| CD4 Referral & Lay Counselor | Active comparator | Other: CD4 Referral, Behavioral: Lay Counselor Follow-upHIV positive persons not on ART at enrollment, randomized to referral for CD4 testing and lay counselor follow up |
| CD4 Referral & Clinic Referral | Active comparator | Other: CD4 Referral, Behavioral: Clinic ReferralHIV positive persons not on ART at enrollment, randomized to referral for CD4 testing and referral to clinic |
| Circumcision - SMS Reminder | Active comparator | Behavioral: SMS ReminderHIV negative uncircumcised males, randomized to SMS reminder for male circumcision |
| Circumcision - Lay Counselor | Active comparator | Behavioral: Lay Counselor Follow-upHIV negative uncircumcised males, randomized to lay counselor follow-up for male circumcision |
| Circumcision - Promotion | Active comparator | Behavioral: Circumcision PromotionHIV negative uncircumcised males, randomized to promotion of male circumcision at the time of HIV testing |
| POC VL | Active comparator | Other: POC VLHIV positive persons on ART, randomized to POC viral load testing |
| Laboratory based VL assay | Active comparator | Other: Laboratory based VL assayHIV positive persons on ART, randomized to laboratory based viral load testing |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Reside in the study community
- Must be 16 years or older
- Able and willing to provide informed consent/assent for study procedures
- HIV negative uncircumcised men must be age 16 - 49 years and have access to secure text messaging to be randomized to strategies for male circumcision.
Key exclusion criteria (1 listed)
- N/A
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| POC CD4 TestingPoint of Care CD4 testing | Other | POC CD4 & Clinic Accompaniment, POC CD4 & Clinic Referral, POC CD4 & Lay Counselor |
| CD4 ReferralReferral to CD4 testing | Other | CD4 Referral & Clinic Accompaniment, CD4 Referral & Clinic Referral, CD4 Referral & Lay Counselor |
| Lay Counselor Follow-upFollow-up from a lay counselor | Behavioural | CD4 Referral & Lay Counselor, Circumcision - Lay Counselor, POC CD4 & Lay Counselor |
| Clinic AccompanimentAccompaniment to the clinic by a counselor | Behavioural | CD4 Referral & Clinic Accompaniment, POC CD4 & Clinic Accompaniment |
| Clinic ReferralReferral to clinic | Behavioural | CD4 Referral & Clinic Referral, POC CD4 & Clinic Referral |
| SMS ReminderSMS reminder for male circumcision | Behavioural | Circumcision - SMS Reminder |
| Circumcision PromotionPromotion of male circumcision at the time of HIV testing | Behavioural | Circumcision - Promotion |
| POC VLPOC VL testing for HIV infected persons on ART | Other | POC VL |
| Laboratory based VL assayLaboratory based viral load testing for HIV infected persons on ART | Other | Laboratory based VL assay |
Primary outcome
Linkage to care for HIV infected persons not on treatment following a point-of care CD4 count compared to referral to clinic for CD4 testing
Time frame: Up to 12 Months
Proportion of HIV positive individuals in the POC CD4 arm who visit a clinic, obtain a staging CD4 test, initiate ART if eligible, or have a viral load <50 copies/mL within 9 months compared to those in the clinic referral arm.
Uptake of male circumcision referral among HIV-uninfected men with either promotion at point of HIV testing, SMS follow-up or lay-counselor follow-up visits
Time frame: Up to 9 months
Proportion of HIV-uninfected men who visit a male circumcision clinic or outreach venue for information about circumcision and proportion who report being circumcised by month 3 and 9 in the lay-counselor arm compared to the SMS follow-up arm, and male circumcision promotion at HIV testing arm
Linkage to care for HIV infected persons after lay counselor follow-up, accompaniment to HIV clinic by lay counselor, or clinic referral
Time frame: Up to 12 months
Proportion of HIV positive individuals not on ART at baseline who visit a clinic, obtain a staging CD4 test, initiate ART if eligible, or have a viral load <50 copies/mL within 9 months in the lay counselor follow-up arm compared to the accompaniment and clinic referral arms
1 secondary outcome
POC viral load testing impact on ART adherence and viral suppression compared to standard laboratory testing
Time frame: Up to 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2015.
- Derived from this study: PubMed 27126488Barnabas RV, van Rooyen H, Tumwesigye E, Brantley J, Baeten JM, van Heerden A, Turyamureeba B, Joseph P, Krows M, Thomas KK, Schaafsma TT, Hughes JP, Celum C. Uptake of antiretroviral therapy and male circumcision after community-based HIV testing and strategies for linkage to care versus standard clinic referral: a multisite, open-label, randomised controlled trial in South Africa and Uganda. Lancet HIV. 2016 May;3(5):e212-20. doi: 10.1016/S2352-3018(16)00020-5. Epub 2016 Mar 10.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Connie Celum, MD, MPH principal investigator
University of Washington
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing POC CD4 Testing, CD4 Referral and Lay Counselor Follow-up in people with HIV, run by University of Washington at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in South Africa, Uganda. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Linkage to care for HIV infected persons not on treatment following a point-of care CD4 count compared to referral to clinic for CD4 testing (time frame: Up to 12 Months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02038582, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2015.