HIV/AIDSDoDoPiNCT01459120
Comparison of Door-to-door Versus Community Gathering to Provide HIV Counseling and Testing Services in Rural Lesotho
A study testing Door-to-door and Pitso in people with HIV/AIDS and Tuberculosis, run by SolidarMed at 2 sites in Lesotho.
Trial summary
The purpose of this trial is to determine if door-to-door is more effective than community gathering in providing voluntary HIV counseling and testing (VCT) in communities in rural Lesotho. The voluntary HIV counseling and testing will be proposed as an integrated part of a package of proposed services. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- HIV/AIDS, Tuberculosis, Diabetes Mellitus
- What is being tested?
- Door-to-door and Pitso
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,800 participants
- Where
- 2 sitesLesotho
- Study dates
- Oct 2011to Feb 2012
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Not already known to be HIV-positive
- Resident in the catchment area of the health center where the campaign is conducted
- Provision of written informed consent to participate (signed by writing or fingerprint)
- In case of children: Provision of written informed consent by an adult care-taker
Who cannot join
None listed.
Trial locations and contacts
2 sites in 1 country.
Lesotho2 sites
Seboche Hospital
Seboche, Botha-Bothe, P.O. 304
Paray Hospital
Thaba-Tseka, Thaba-Tseka
About this study
Official title: Comparing Door-to-door Versus Community Gathering in Providing HIV Counseling and Testing Within an Integrated Primary Health Care Package: a Cluster Randomized Trial in Rural Lesotho
The purpose of this trial is to determine if door-to-door is more effective than community gathering in providing voluntary HIV counseling and testing (VCT) in communities in rural Lesotho. The voluntary HIV counseling and testing will be proposed as an integrated part of a package of proposed services. The package consists of: Blood-pressure measurement, blood-glucose measurement, Body-mass-index (adults), weight for height (children), catch-up vaccinations, deworming (children) Vitamin A (children \& young women), family planning for eligible women, Tuberculosis screening and HIV counseling and testing.
Read the detailed description
12 health centers (clusters) in rural Lesotho are matched according to their routine performance in VCT and enrollment into chronic HIV/AIDS care (average numbers tested positive and enrolled into HIV/AIDS care per month per facility). After matching, 6 health centers are randomly assigned to perform door-to-door VCT, whereas the others perform the traditional community gathering approach (called "pitso" in Sesotho). Within the catchment area of each health center five campaigns in five different, randomly selected villages, are held (one day VCT campaign per village). Within each cluster another five villages are randomly selected who do not get a particular campaign and serve as a control for each cluster. In each matched cluster-pair, both health centers conduct the five campaigns during the same week (one conducting it as door-to-door, the other one conducting it through "pitsos" (community gathering)).
Both approaches receive the same resources in terms of finances, time spending doing the VCT-campaign and human resources.
- Conditions
- HIV/AIDS, Tuberculosis, Diabetes Mellitus, Arterial Hypertension
- Being tested
- Door-to-door, Pitso
- Keywords
- Home-based HIV-testing, Voluntary Counseling and Testing, Community based testing, HIV/AIDS, Lesotho
- Medical subject headings
- Acquired Immunodeficiency Syndrome, Tuberculosis, Diabetes Mellitus, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Door-to-doorOther
Health workers propose the integrated service package including VCT at the peoples' homes (home-based testing).
PitsoOther
Health care workers propose the integrated service package including VCT through community gatherings ("Pitso").
| Study group | Role | What they receive |
|---|---|---|
| Door-to-Door | Experimental | Health care workers propose the integrated service package including VCT at the peoples' homes. Receives: Other: Door-to-door |
| Pitso | Active comparator | Health care workers propose the integrated service package including VCT through community gatherings ("pitso"). Receives: Other: Pitso |
| control | No intervention | Within each cluster (catchment area of a health center), five villages are randomly chosen as comparators on cluster level. These villages get no particular intervention (VCT-campaign). However, routine services continue to be provided. These villages serve as a control for the third primary outcome that assesses the overall numbers newly enrolled into chronic HIV/AIDS care at facility-level. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of newly tested HIV-positive clients over all clients tested for HIV during the campaigns
Proportion refers to the proportion of newly tested HIV-positive clients among all clients tested for HIV during the voluntary counselling and testing campaigns in each arm.
Proportion of clients newly tested HIV-positive who enrolled into HIV/AIDS care within one month over all clients newly tested HIV-positive during the campaigns
One month after the campaigns, enrollment of clients who newly tested HIV-positive at the campaign is assessed at the facilities based on the clinics' registers.
Measured: 4 weeks after tested positive
Overall number newly tested HIV-positive and enrolled into chronic HIV/AIDS-care at each facility
Between the two study-arms, the overall numbers will be compared in two ways:
- Total number positively tested and enrolled into care at the facility during the month after the campaign (this refers to the overall number at facility-level. Irrespective if these patients were tested during one of the campaigns or during routine activities at the facility)
- Total number positively tested and enrolled into care from the 5 villages where campaigns were held as compared to the five villages where no campaigns were held.
Measured: 4 weeks after campaign
Absolute number of newly tested HIV-positive clients
Refers to the overall number newly tested HIV-positive during the campaigns in both arms
Absolute number of clients newly tested HIV-positive who enrolled into HIV/AIDS care
This refers to the absolute number newly tested HIV-positive during the campaigns who enrolled thereafter into chronic HIV/AIDS care within one month
Measured: 4 weeks after tested HIV-positive
Secondary outcomes (10)
CD4-count among clients newly tested HIV-positive
CD4-counts will be measured on site using a Point-of-care machine.
Clinical WHO-stage among clients newly tested HIV-positive
Proportion of clients screened positive for Tuberculosis during the campaigns
All clients accessing services (irrespective of HIV-status) will be screened for TB by a nurse. Clients with a positive screening are provided sputum bottles and are entered in the Tuberculosis-suspect register.
Proportion of first-time HIV-testers among all clients accessing the testing services
Proportion of clients with positive tuberculosis screening who return 3 sputum-bottles within ≤ 5 days to the facility
Tuberculosis-suspect registers and tuberculosis registers at the facility are used for verification
Measured: 5 days after the campaign was held
Proportion of clients with a positive Tuberculosis-screening who return their sputum-bottles and who have at least one AFB-positive smear.
Tuberculosis suspect registers and Tuberculosis registers at the facility are used for verification.
Measured: 5 days after the campaign was held
Demographic characteristics of clients accessing the voluntary counseling and testing services
Absolute number of clients accessing the services at the campaigns who have a positive screening for Tuberculosis
Absolute number of clients with positive tuberculosis screening who return 3 sputum-bottles within ≤ 5 days to the facility
Measured: ≤ 5 days after the campaigns
Absolute number of clients with a positive Tuberculosis-screening who return their sputum-bottles and who have at least one AFB-positive smear.
Measured: ≤ 5 days after the campaign
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2011 (estimated)
- Study startOct 2011
- Primary completionFeb 2012
- Study completionFeb 2012
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 HIV/AIDSStudies 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 N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- SolidarMed
- Sponsor type
- University, hospital or other
- Collaborators
- Paray Mission Hospital, Thaba-Tseka, Seboche Hospital, Botha-Bothe
- Responsible party
- Principal investigator, Niklaus Labhardt, SolidarMed
- Investigators
- Motlomelo Masetsibi, Principal investigator, SolidarMedNiklaus Labhardt, MD, MIH, Study director, SolidarMedKarolin Pfeiffer, MD, McommH, Study chair, SolidarMed
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01459120
- Sponsor's protocol ID
- DoDoPi-1
- Acronym
- DoDoPi
- Status last verified
- Feb 2012
- First submitted
- 18 Oct 2011
- Last updated
- 9 Feb 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Labhardt ND, Motlomelo M, Cerutti B, Pfeiffer K, Kamele M, Hobbins MA, Ehmer J. Home-based versus mobile clinic HIV testing and counseling in rural Lesotho: a cluster-randomized trial. PLoS Med. 2014 Dec 16;11(12):e1001768. doi: 10.1371/journal.pmed.1001768. eCollection 2014 Dec.
PubMed 25513807
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Door-to-door Versus Community Gathering in Providing HIV Counseling and Testing Within an Integrated Primary Health Care Package: a Cluster Randomized Trial in Rural Lesotho
- ClinicalTrials.gov ID
- NCT01459120
- Acronym / sponsor ID
- DoDoPi / DoDoPi-1
- Conditions
- HIV/AIDS, Tuberculosis, Diabetes Mellitus, Arterial Hypertension
- Keywords
- Home-based HIV-testing, Voluntary Counseling and Testing, Community based testing, HIV/AIDS, Lesotho
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,800 participants (estimated)
- Lead sponsor
- SolidarMedUniversity, hospital or other
- Collaborators
- Paray Mission Hospital, Thaba-Tseka, Seboche Hospital, Botha-Bothe
- Study start
- Oct 2011
- Primary completion
- Feb 2012 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 25 Oct 2011 (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 trial is to determine if door-to-door is more effective than community gathering in providing voluntary HIV counseling and testing (VCT) in communities in rural Lesotho. The voluntary HIV counseling and testing will be proposed as an integrated part of a package of proposed services. The package consists of: Blood-pressure measurement, blood-glucose measurement, Body-mass-index (adults), weight for height (children), catch-up vaccinations, deworming (children) Vitamin A (children \& young women), family planning for eligible women, Tuberculosis screening and HIV counseling and testing.
Detailed description
12 health centers (clusters) in rural Lesotho are matched according to their routine performance in VCT and enrollment into chronic HIV/AIDS care (average numbers tested positive and enrolled into HIV/AIDS care per month per facility). After matching, 6 health centers are randomly assigned to perform door-to-door VCT, whereas the others perform the traditional community gathering approach (called "pitso" in Sesotho). Within the catchment area of each health center five campaigns in five different, randomly selected villages, are held (one day VCT campaign per village). Within each cluster another five villages are randomly selected who do not get a particular campaign and serve as a control for each cluster. In each matched cluster-pair, both health centers conduct the five campaigns during the same week (one conducting it as door-to-door, the other one conducting it through "pitsos" (community gathering)).
Both approaches receive the same resources in terms of finances, time spending doing the VCT-campaign and human resources.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Door-to-Door | Experimental | Other: Door-to-doorHealth care workers propose the integrated service package including VCT at the peoples' homes. |
| Pitso | Active comparator | Other: PitsoHealth care workers propose the integrated service package including VCT through community gatherings ("pitso"). |
| control | No intervention | –Within each cluster (catchment area of a health center), five villages are randomly chosen as comparators on cluster level. These villages get no particular intervention (VCT-campaign). However, routine services continue to be provided. These villages serve as a control for the third primary outcome that assesses the overall numbers newly enrolled into chronic HIV/AIDS care at facility-level. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Not already known to be HIV-positive
- Resident in the catchment area of the health center where the campaign is conducted
- Provision of written informed consent to participate (signed by writing or fingerprint)
- In case of children: Provision of written informed consent by an adult care-taker
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Door-to-doorHealth workers propose the integrated service package including VCT at the peoples' homes (home-based testing). | Other | Door-to-Door |
| PitsoHealth care workers propose the integrated service package including VCT through community gatherings ("Pitso"). | Other | Pitso |
Primary outcome
Proportion of newly tested HIV-positive clients over all clients tested for HIV during the campaigns
Proportion refers to the proportion of newly tested HIV-positive clients among all clients tested for HIV during the voluntary counselling and testing campaigns in each arm.
Proportion of clients newly tested HIV-positive who enrolled into HIV/AIDS care within one month over all clients newly tested HIV-positive during the campaigns
Time frame: 4 weeks after tested positive
One month after the campaigns, enrollment of clients who newly tested HIV-positive at the campaign is assessed at the facilities based on the clinics' registers.
Overall number newly tested HIV-positive and enrolled into chronic HIV/AIDS-care at each facility
Time frame: 4 weeks after campaign
Between the two study-arms, the overall numbers will be compared in two ways: 1. Total number positively tested and enrolled into care at the facility during the month after the campaign (this refers to the overall number at facility-level. Irrespective if these patients were tested during one of the campaigns or during routine activities at the facility) 2. Total number positively tested and enrolled into care from the 5 villages where campaigns were held as compared to the five villages where no campaigns were held.
Absolute number of newly tested HIV-positive clients
Refers to the overall number newly tested HIV-positive during the campaigns in both arms
Absolute number of clients newly tested HIV-positive who enrolled into HIV/AIDS care
Time frame: 4 weeks after tested HIV-positive
This refers to the absolute number newly tested HIV-positive during the campaigns who enrolled thereafter into chronic HIV/AIDS care within one month
10 secondary outcomes
CD4-count among clients newly tested HIV-positive
Clinical WHO-stage among clients newly tested HIV-positive
Proportion of clients screened positive for Tuberculosis during the campaigns
Proportion of first-time HIV-testers among all clients accessing the testing services
Proportion of clients with positive tuberculosis screening who return 3 sputum-bottles within ≤ 5 days to the facility
Time frame: 5 days after the campaign was held
Proportion of clients with a positive Tuberculosis-screening who return their sputum-bottles and who have at least one AFB-positive smear.
Time frame: 5 days after the campaign was held
Demographic characteristics of clients accessing the voluntary counseling and testing services
Absolute number of clients accessing the services at the campaigns who have a positive screening for Tuberculosis
Absolute number of clients with positive tuberculosis screening who return 3 sputum-bottles within ≤ 5 days to the facility
Time frame: ≤ 5 days after the campaigns
Absolute number of clients with a positive Tuberculosis-screening who return their sputum-bottles and who have at least one AFB-positive smear.
Time frame: ≤ 5 days after the campaign
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 9 Feb 2012.
- Derived from this study: PubMed 25513807Labhardt ND, Motlomelo M, Cerutti B, Pfeiffer K, Kamele M, Hobbins MA, Ehmer J. Home-based versus mobile clinic HIV testing and counseling in rural Lesotho: a cluster-randomized trial. PLoS Med. 2014 Dec 16;11(12):e1001768. doi: 10.1371/journal.pmed.1001768. eCollection 2014 Dec.
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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.
Motlomelo Masetsibi principal investigator
SolidarMed
Niklaus Labhardt, MD, MIH study director
SolidarMed
Karolin Pfeiffer, MD, McommH study chair
SolidarMed
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Door-to-door and Pitso in people with HIV/AIDS and Tuberculosis, run by SolidarMed at 2 sites in Lesotho.
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 0 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 9 Feb 2012. 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 Lesotho. 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?
Proportion of newly tested HIV-positive clients over all clients tested for HIV during the campaigns. The study lists 5 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 NCT01459120, 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 9 Feb 2012.