HIVPhase 4BCPPNCT01965470

Botswana Combination Prevention Project

A Phase 4 study testing Combination Prevention and Enhanced Care in people with HIV, run by Centers for Disease Control and Prevention at 1 site in Botswana.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The BCPP study is designed to test the hypothesis that implementing an enhanced combination prevention package which includes provision of ART to all participants, regardless of CD4 count or HIV disease severity, will impact the HIV/AIDS epidemic by significantly reducing population-level, cumulative HIV incidence in… Read more about this study

Who is it for?: Ages 16 to 64 years
Conditions the study is for: HIV
What is being tested?: Combination Prevention and Enhanced Care
Could I receive a placebo?: No, everyone receives an active treatment
How many people: Not given
Where: 1 siteBotswana
Study dates: 30 Oct 2013to 26 Jul 2018
Phase: Phase 4
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 to 64 years
All sexes
No healthy volunteers
Child, Adult

Who may be able to join

Protocol #1 - Baseline Household Survey (BHS): Permanent or part-time study community resident in any of the 30 study communities; Botswana citizen or spouse of a Botswana citizen; able to provide informed consent if ≥18 years old, or able to provide assent to complement a guardian's permission, if a minor (aged 16 or 17).
Protocol #3 - Expanded treatment cohort: HIV-infected persons in Combination Prevention communities who are not yet on ART and are able to provide informed consent if ≥18 years old, or able to provide assent to complement a guardian's permission, if a minor (aged 16 or 17).

Who cannot join

Persons who do not meet inclusion criteria.

Trial locations and contacts

1 site in 1 country.

Botswana1 site

Botswana communities and Botswana Ministry of Health clinics
Multiple Locations, Multiple

Other trials in Botswana

About this study

Official title: Botswana Combination Prevention Project: -Evaluation Protocol (Protocol #1): Research Design and Impact Evaluation -Closed Clinical Cohort Protocol (Protocol #3) Implementation, Monitoring and Evaluation of Combination HIV Prevention Interventions in Rural and Peri-Urban Communities in Botswana

Conditions: HIV
Being tested: Combination Prevention, Enhanced Care

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Combination PreventionOther
Enhanced CareOther

Study groups in NCT01965470
Study group	Role	What they receive
Combination Prevention	Experimental	* Scale-up of HTC services during 2 annual HTC campaigns, with a target of >90% of adults having documentation of their HIV-infected status or documentation of an HIV-negative test in the preceding 12 months. * Scale-up of universal ART for all HIV-infected adults, with a target of >93% of HIV positive adults receiving ART. * Scale-up of retention in care and adherence interventions, with a target of ensuring that >95% of HIV-infected adults are virally suppressed with HIV-1 RNA <400 copies per ML.. * Scale-up of linkage to MC services, with a target of ensuring >60% of HIV-negative men are circumcised. * Rapid strengthening of PMTCT services, with a target of >90% of women initiated on indefinite ART (Option B+) during pregnancy remaining in care and on treatment at 12 months post-delivery. Receives: Other: Combination Prevention
Enhanced Care	Active comparator	Enhanced Care Communities will receive guidance and improved technical support for quality management and data systems at all local clinics at which individuals receive HIV care and treatment. Receives: Other: Enhanced Care

What is being measured

The primary outcome is the main question the study is designed to answer.

Population-level, cumulative HIV incidence
Population-level cumulative HIV incidence will be measured in a cohort of HIV-negative persons identified from a 20% sample of eligible households in the 30 study communities followed annually.
Measured: 3 years

Secondary outcomes (2)

2. Population-level uptake of HIV testing and counseling (HTC), ART, VL Suppression, male circumcision (MC), and PMTCT services
Population-level uptake of each intervention will be measured in an annual survey of the 20% sample of eligible households in the 30 study communities and through analysis of routine program monitoring data.
Measured: 3 years
Cost per additional infection averted
Measured: 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

30 Oct 201326 Jul 2018

First posted18 Oct 2013 (estimated)
Study start30 Oct 2013
Primary completion26 Jul 2018
Study completion26 Jul 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (36)Papers the sponsor has linked to this study.
Other trials for HIVStudies of the same condition, open and under way.
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 4
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups

IDs, dates and publications

ClinicalTrials.gov ID: NCT01965470
Sponsor's protocol ID: CDC-CGH-6475
Acronym: BCPP
Status last verified: Nov 2022
First submitted: 16 Oct 2013
Last updated: 14 Nov 2022
Results posted: No
Data monitoring committee: Yes

Publications

Moyo S, Gaseitsiwe S, Mohammed T, Pretorius Holme M, Wang R, Kotokwe KP, Boleo C, Mupfumi L, Yankinda EK, Chakalisa U, van Widenfelt E, Gaolathe T, Mmalane MO, Dryden-Peterson S, Mine M, Lebelonyane R, Bennett K, Leidner J, Wirth KE, Tchetgen Tchetgen E, Powis K, Moore J, Clarke WA, Lockman S, Makhema JM, Essex M, Novitsky V. Cross-sectional estimates revealed high HIV incidence in Botswana rural communities in the era of successful ART scale-up in 2013-2015. PLoS One. 2018 Oct 24;13(10):e0204840. doi: 10.1371/journal.pone.0204840. eCollection 2018.
PubMed 30356287
Novitsky V, Gaolathe T, Mmalane M, Moyo S, Chakalisa U, Yankinda EK, Marukutira T, Holme MP, Sekoto T, Gaseitsiwe S, Musonda R, van Widenfelt E, Powis KM, Khan N, Dryden-Peterson S, Bennett K, Wirth KE, Tchetgen ET, Bachanas P, Mills LA, Lebelonyane R, El-Halabi S, Makhema J, Lockman S, Essex M. Lack of Virological Suppression Among Young HIV-Positive Adults in Botswana. J Acquir Immune Defic Syndr. 2018 Aug 15;78(5):557-565. doi: 10.1097/QAI.0000000000001715.
PubMed 29771781
Moyo S, Gaseitsiwe S, Powis KM, Pretorius Holme M, Mohammed T, Zahralban-Steele M, Yankinde EK, Maphorisa C, Abrams W, Lebelonyane R, Manyake K, Sekoto T, Mmalane M, Gaolathe T, Wirth KE, Makhema J, Lockman S, Clarke W, Essex M, Novitsky V. Undisclosed antiretroviral drug use in Botswana: implication for national estimates. AIDS. 2018 Jul 17;32(11):1543-1546. doi: 10.1097/QAD.0000000000001862.
PubMed 29762166
Novitsky V, Prague M, Moyo S, Gaolathe T, Mmalane M, Yankinda EK, Chakalisa U, Lebelonyane R, Khan N, Powis KM, Widenfelt E, Gaseitsiwe S, Dryden-Peterson SL, Holme MP, De Gruttola V, Bachanas P, Makhema J, Lockman S, Essex M. High HIV-1 RNA Among Newly Diagnosed People in Botswana. AIDS Res Hum Retroviruses. 2018 Mar;34(3):300-306. doi: 10.1089/AID.2017.0214. Epub 2018 Jan 17.
PubMed 29214845
Moyo S, Mohammed T, Wirth KE, Prague M, Bennett K, Holme MP, Mupfumi L, Sebogodi P, Moraka NO, Boleo C, Maphorisa CN, Seraise B, Gaseitsiwe S, Musonda RM, van Widenfelt E, Powis KM, Gaolathe T, Tchetgen Tchetgen EJ, Makhema JM, Essex M, Lockman S, Novitsky V. Point-of-Care Cepheid Xpert HIV-1 Viral Load Test in Rural African Communities Is Feasible and Reliable. J Clin Microbiol. 2016 Dec;54(12):3050-3055. doi: 10.1128/JCM.01594-16. Epub 2016 Oct 12.
PubMed 27733636
Gaolathe T, Wirth KE, Holme MP, Makhema J, Moyo S, Chakalisa U, Yankinda EK, Lei Q, Mmalane M, Novitsky V, Okui L, van Widenfelt E, Powis KM, Khan N, Bennett K, Bussmann H, Dryden-Peterson S, Lebelonyane R, El-Halabi S, Mills LA, Marukutira T, Wang R, Tchetgen EJ, DeGruttola V, Essex M, Lockman S; Botswana Combination Prevention Project study team. Botswana's progress toward achieving the 2020 UNAIDS 90-90-90 antiretroviral therapy and virological suppression goals: a population-based survey. Lancet HIV. 2016 May;3(5):e221-30. doi: 10.1016/S2352-3018(16)00037-0. Epub 2016 Mar 24.
PubMed 27126489
Novitsky V, Zahralban-Steele M, McLane MF, Moyo S, van Widenfelt E, Gaseitsiwe S, Makhema J, Essex M. Correction for Novitsky et al., Long-Range HIV Genotyping Using Viral RNA and Proviral DNA for Analysis of HIV Drug Resistance and HIV Clustering. J Clin Microbiol. 2016 Apr;54(4):1175. doi: 10.1128/JCM.00190-16. No abstract available.
PubMed 27016593
Perriat D, Balzer L, Hayes R, Lockman S, Walsh F, Ayles H, Floyd S, Havlir D, Kamya M, Lebelonyane R, Mills LA, Okello V, Petersen M, Pillay D, Sabapathy K, Wirth K, Orne-Gliemann J, Dabis F; Universal Test and Treat Trials Consortium (UT3C). Comparative assessment of five trials of universal HIV testing and treatment in sub-Saharan Africa. J Int AIDS Soc. 2018 Jan;21(1):e25048. doi: 10.1002/jia2.25048.
PubMed 29314658
Novitsky V, Zahralban-Steele M, Moyo S, Nkhisang T, Maruapula D, McLane MF, Leidner J, Bennett K; PANGEA Consortium; Wirth KE, Gaolathe T, Kadima E, Chakalisa U, Pretorius Holme M, Lockman S, Mmalane M, Makhema J, Gaseitsiwe S, DeGruttola V, Essex M. Mapping of HIV-1C Transmission Networks Reveals Extensive Spread of Viral Lineages Across Villages in Botswana Treatment-as-Prevention Trial. J Infect Dis. 2020 Nov 15;222(10):1670-1680. doi: 10.1093/infdis/jiaa276. Epub 2020 Jun 3.
PubMed 32492145
Lebelonyane R, Mills LA, Mogorosi C, Ussery F, Marukutira T, Theu J, Kapanda M, Matambo S, Block L, Raizes E, Makhema J, Lockman S, Bachanas P, Moore J, Jarvis JN. Advanced HIV disease in the Botswana combination prevention project: prevalence, risk factors, and outcomes. AIDS. 2020 Dec 1;34(15):2223-2230. doi: 10.1097/QAD.0000000000002627.
PubMed 32694412
Lockman S, Holme MP, Makhema J, Bachanas P, Moore J, Wirth KE, Lebelonyane R, Essex M. Implementation of Universal HIV Testing and Treatment to Reduce HIV Incidence in Botswana: the Ya Tsie Study. Curr HIV/AIDS Rep. 2020 Oct;17(5):478-486. doi: 10.1007/s11904-020-00523-0.
PubMed 32797382
Lebelonyane R, Bachanas P, Block L, Ussery F, Abrams W, Roland M, Theu J, Kapanda M, Matambo S, Lockman S, Gaolathe T, Makhema J, Moore J, Jarvis JN. Rapid antiretroviral therapy initiation in the Botswana Combination Prevention Project: a quasi-experimental before and after study. Lancet HIV. 2020 Aug;7(8):e545-e553. doi: 10.1016/S2352-3018(20)30187-9.
PubMed 32763218
Alwano MG, Bachanas P, Block L, Roland M, Sento B, Behel S, Lebelonyane R, Wirth K, Ussery F, Bapati W, Motswere-Chirwa C, Abrams W, Ussery G, Miller JA, Bile E, Fonjungo P, Kgwadu A, Holme MP, Del Castillo L, Gaolathe T, Leme K, Majingo N, Lockman S, Makhema J, Bock N, Moore J. Increasing knowledge of HIV status in a country with high HIV testing coverage: Results from the Botswana Combination Prevention Project. PLoS One. 2019 Nov 25;14(11):e0225076. doi: 10.1371/journal.pone.0225076. eCollection 2019.
PubMed 31765394
Kebaabetswe P, Manyake K, Kadima E, Auletta-Young C, Chakalisa U, Sekoto T, Dintwa OM, Mmalane M, Makhema J, Lebelonyane R, Bachanas P, Plank R, Gaolathe T, Lockman S, Holme MP. Barriers and facilitators to linkage to care and ART initiation in the setting of high ART coverage in Botswana. AIDS Care. 2020 Jun;32(6):722-728. doi: 10.1080/09540121.2019.1640843. Epub 2019 Jul 12.
PubMed 31298037
Chakalisa U, Wirth K, Bennett K, Kadima E, Manyake K, Gaolathe T, Bachanas P, Marukutira T, Lebelonyane R, Dryden-Peterson S, Butler L, Mmalane M, Makhema J, Roland ME, Pretorius-Holme M, Essex M, Lockman S, Powis KM. Self-reported risky sexual practices among adolescents and young adults in Botswana. South Afr J HIV Med. 2019 Jun 26;20(1):899. doi: 10.4102/sajhivmed.v20i1.899. eCollection 2019.
PubMed 31308965

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All HIV trials

Study at a glance

From the registry record, last updated by the sponsor on 14 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Botswana Combination Prevention Project: -Evaluation Protocol (Protocol #1): Research Design and Impact Evaluation -Closed Clinical Cohort Protocol (Protocol #3) Implementation, Monitoring and Evaluation of Combination HIV Prevention Interventions in Rural and Peri-Urban Communities in Botswana
ClinicalTrials.gov ID: NCT01965470
Acronym / sponsor ID: BCPP / CDC-CGH-6475
Conditions: HIV
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Lead sponsor: Centers for Disease Control and PreventionUS federal agency
Collaborators: Botswana Harvard AIDS Institute Partnership, Botswana Ministry of Health, Harvard School of Public Health (HSPH), Tebelopele Voluntary Counseling and Testing Center
Study start: 30 Oct 2013 (actual)
Primary completion: 26 Jul 2018 (actual)
Study completion: 26 Jul 2018 (actual)
First posted: 18 Oct 2013 (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.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Number of arms: 2

Arm	Type	Receives
Combination Prevention	Experimental	Other: Combination Prevention* Scale-up of HTC services during 2 annual HTC campaigns, with a target of >90% of adults having documentation of their HIV-infected status or documentation of an HIV-negative test in the preceding 12 months. * Scale-up of universal ART for all HIV-infected adults, with a target of >93% of HIV positive adults receiving ART. * Scale-up of retention in care and adherence interventions, with a target of ensuring that >95% of HIV-infected adults are virally suppressed with HIV-1 RNA <400 copies per ML.. * Scale-up of linkage to MC services, with a target of ensuring >60% of HIV-negative men are circumcised. * Rapid strengthening of PMTCT services, with a target of >90% of women initiated on indefinite ART (Option B+) during pregnancy remaining in care and on treatment at 12 months post-delivery.
Enhanced Care	Active comparator	Other: Enhanced CareEnhanced Care Communities will receive guidance and improved technical support for quality management and data systems at all local clinics at which individuals receive HIV care and treatment.

Who may qualify

Ages: 16 to 64 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult

Key inclusion criteria (2 listed)

Protocol #1 - Baseline Household Survey (BHS): Permanent or part-time study community resident in any of the 30 study communities; Botswana citizen or spouse of a Botswana citizen; able to provide informed consent if ≥18 years old, or able to provide assent to complement a guardian's permission, if a minor (aged 16 or 17).
Protocol #3 - Expanded treatment cohort: HIV-infected persons in Combination Prevention communities who are not yet on ART and are able to provide informed consent if ≥18 years old, or able to provide assent to complement a guardian's permission, if a minor (aged 16 or 17).

Key exclusion criteria (1 listed)

Persons who do not meet inclusion criteria.

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
Combination Prevention	Other	Combination Prevention
Enhanced Care	Other	Enhanced Care

Primary outcome

Population-level, cumulative HIV incidence
Time frame: 3 years
Population-level cumulative HIV incidence will be measured in a cohort of HIV-negative persons identified from a 20% sample of eligible households in the 30 study communities followed annually.

2 secondary outcomes

2. Population-level uptake of HIV testing and counseling (HTC), ART, VL Suppression, male circumcision (MC), and PMTCT services
Time frame: 3 years
Cost per additional infection averted
Time frame: 3 years

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 14 Nov 2022.
Background: PubMed 30356287Moyo S, Gaseitsiwe S, Mohammed T, Pretorius Holme M, Wang R, Kotokwe KP, Boleo C, Mupfumi L, Yankinda EK, Chakalisa U, van Widenfelt E, Gaolathe T, Mmalane MO, Dryden-Peterson S, Mine M, Lebelonyane R, Bennett K, Leidner J, Wirth KE, Tchetgen Tchetgen E, Powis K, Moore J, Clarke WA, Lockman S, Makhema JM, Essex M, Novitsky V. Cross-sectional estimates revealed high HIV incidence in Botswana rural communities in the era of successful ART scale-up in 2013-2015. PLoS One. 2018 Oct 24;13(10):e0204840. doi: 10.1371/journal.pone.0204840. eCollection 2018.
Background: PubMed 29771781Novitsky V, Gaolathe T, Mmalane M, Moyo S, Chakalisa U, Yankinda EK, Marukutira T, Holme MP, Sekoto T, Gaseitsiwe S, Musonda R, van Widenfelt E, Powis KM, Khan N, Dryden-Peterson S, Bennett K, Wirth KE, Tchetgen ET, Bachanas P, Mills LA, Lebelonyane R, El-Halabi S, Makhema J, Lockman S, Essex M. Lack of Virological Suppression Among Young HIV-Positive Adults in Botswana. J Acquir Immune Defic Syndr. 2018 Aug 15;78(5):557-565. doi: 10.1097/QAI.0000000000001715.
Background: PubMed 29762166Moyo S, Gaseitsiwe S, Powis KM, Pretorius Holme M, Mohammed T, Zahralban-Steele M, Yankinde EK, Maphorisa C, Abrams W, Lebelonyane R, Manyake K, Sekoto T, Mmalane M, Gaolathe T, Wirth KE, Makhema J, Lockman S, Clarke W, Essex M, Novitsky V. Undisclosed antiretroviral drug use in Botswana: implication for national estimates. AIDS. 2018 Jul 17;32(11):1543-1546. doi: 10.1097/QAD.0000000000001862.
Background: PubMed 29214845Novitsky V, Prague M, Moyo S, Gaolathe T, Mmalane M, Yankinda EK, Chakalisa U, Lebelonyane R, Khan N, Powis KM, Widenfelt E, Gaseitsiwe S, Dryden-Peterson SL, Holme MP, De Gruttola V, Bachanas P, Makhema J, Lockman S, Essex M. High HIV-1 RNA Among Newly Diagnosed People in Botswana. AIDS Res Hum Retroviruses. 2018 Mar;34(3):300-306. doi: 10.1089/AID.2017.0214. Epub 2018 Jan 17.
Background: PubMed 27733636Moyo S, Mohammed T, Wirth KE, Prague M, Bennett K, Holme MP, Mupfumi L, Sebogodi P, Moraka NO, Boleo C, Maphorisa CN, Seraise B, Gaseitsiwe S, Musonda RM, van Widenfelt E, Powis KM, Gaolathe T, Tchetgen Tchetgen EJ, Makhema JM, Essex M, Lockman S, Novitsky V. Point-of-Care Cepheid Xpert HIV-1 Viral Load Test in Rural African Communities Is Feasible and Reliable. J Clin Microbiol. 2016 Dec;54(12):3050-3055. doi: 10.1128/JCM.01594-16. Epub 2016 Oct 12.
Background: PubMed 27126489Gaolathe T, Wirth KE, Holme MP, Makhema J, Moyo S, Chakalisa U, Yankinda EK, Lei Q, Mmalane M, Novitsky V, Okui L, van Widenfelt E, Powis KM, Khan N, Bennett K, Bussmann H, Dryden-Peterson S, Lebelonyane R, El-Halabi S, Mills LA, Marukutira T, Wang R, Tchetgen EJ, DeGruttola V, Essex M, Lockman S; Botswana Combination Prevention Project study team. Botswana's progress toward achieving the 2020 UNAIDS 90-90-90 antiretroviral therapy and virological suppression goals: a population-based survey. Lancet HIV. 2016 May;3(5):e221-30. doi: 10.1016/S2352-3018(16)00037-0. Epub 2016 Mar 24.
Background: PubMed 27016593Novitsky V, Zahralban-Steele M, McLane MF, Moyo S, van Widenfelt E, Gaseitsiwe S, Makhema J, Essex M. Correction for Novitsky et al., Long-Range HIV Genotyping Using Viral RNA and Proviral DNA for Analysis of HIV Drug Resistance and HIV Clustering. J Clin Microbiol. 2016 Apr;54(4):1175. doi: 10.1128/JCM.00190-16. No abstract available.
Background: PubMed 29314658Perriat D, Balzer L, Hayes R, Lockman S, Walsh F, Ayles H, Floyd S, Havlir D, Kamya M, Lebelonyane R, Mills LA, Okello V, Petersen M, Pillay D, Sabapathy K, Wirth K, Orne-Gliemann J, Dabis F; Universal Test and Treat Trials Consortium (UT3C). Comparative assessment of five trials of universal HIV testing and treatment in sub-Saharan Africa. J Int AIDS Soc. 2018 Jan;21(1):e25048. doi: 10.1002/jia2.25048.
Background: PubMed 32492145Novitsky V, Zahralban-Steele M, Moyo S, Nkhisang T, Maruapula D, McLane MF, Leidner J, Bennett K; PANGEA Consortium; Wirth KE, Gaolathe T, Kadima E, Chakalisa U, Pretorius Holme M, Lockman S, Mmalane M, Makhema J, Gaseitsiwe S, DeGruttola V, Essex M. Mapping of HIV-1C Transmission Networks Reveals Extensive Spread of Viral Lineages Across Villages in Botswana Treatment-as-Prevention Trial. J Infect Dis. 2020 Nov 15;222(10):1670-1680. doi: 10.1093/infdis/jiaa276. Epub 2020 Jun 3.
Background: PubMed 32694412Lebelonyane R, Mills LA, Mogorosi C, Ussery F, Marukutira T, Theu J, Kapanda M, Matambo S, Block L, Raizes E, Makhema J, Lockman S, Bachanas P, Moore J, Jarvis JN. Advanced HIV disease in the Botswana combination prevention project: prevalence, risk factors, and outcomes. AIDS. 2020 Dec 1;34(15):2223-2230. doi: 10.1097/QAD.0000000000002627.
Background: PubMed 32797382Lockman S, Holme MP, Makhema J, Bachanas P, Moore J, Wirth KE, Lebelonyane R, Essex M. Implementation of Universal HIV Testing and Treatment to Reduce HIV Incidence in Botswana: the Ya Tsie Study. Curr HIV/AIDS Rep. 2020 Oct;17(5):478-486. doi: 10.1007/s11904-020-00523-0.
Background: PubMed 32763218Lebelonyane R, Bachanas P, Block L, Ussery F, Abrams W, Roland M, Theu J, Kapanda M, Matambo S, Lockman S, Gaolathe T, Makhema J, Moore J, Jarvis JN. Rapid antiretroviral therapy initiation in the Botswana Combination Prevention Project: a quasi-experimental before and after study. Lancet HIV. 2020 Aug;7(8):e545-e553. doi: 10.1016/S2352-3018(20)30187-9.

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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.

Janet S Moore, PhD principal investigator

Centers for Disease Control and Prevention

Myron Essex, DVM, PhD principal investigator

Harvard School of Public Health (HSPH)

Refeletswe Lebelonyane, MD principal investigator

Botswana Ministry of Health

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Combination Prevention and Enhanced Care in people with HIV, run by Centers for Disease Control and Prevention at 1 site in Botswana.

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 2 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 14 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Botswana. 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.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

Population-level, cumulative HIV incidence (time frame: 3 years). 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 NCT01965470, which also lists 36 linked publications.

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 14 Nov 2022.