HIV/AIDSNCT03371914
Costs, Efficiency and the Role of Management in HIV Prevention Interventions for Female Sex Workers in Nigeria
A study testing Management training and data feedback in people with HIV/AIDS, run by Instituto Nacional de Salud Publica, Mexico at 1 site in Nigeria.
Trial summary
This study seeks to measure the costs associated with HIV prevention service delivery to female sex workers (FSW) in Nigeria, as well as examine the relationship between management practices at the community-based organizations (CBOs) and costs. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- HIV/AIDS
- What is being tested?
- Management training and data feedback
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteNigeria
- Study dates
- 12 Aug 2017to 1 Dec 2019
- 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
- Clusters: community-based organizations that serve female sex workers under Society for Family Health, through the SHIPs or Global Fund grants
- Participants: managers ("officers") that oversee the functions of the organization and supervise volunteer staff
Who cannot join
- Clusters: excludes organizations not serving female sex workers and not working under Society for Family Health, through Global Fund or SHIPs grants
- Participants: excludes anyone not explicitly working as a manager overseeing volunteer implementation
Trial locations and contacts
1 site in 1 country.
About this study
This study seeks to measure the costs associated with HIV prevention service delivery to female sex workers (FSW) in Nigeria, as well as examine the relationship between management practices at the community-based organizations (CBOs) and costs. To complete these goals, the study will collect both retrospective and prospective data from CBOs and from centralized information from study partners (Society for Family Health, SFH). In the prospective section of the study, CBOs will be sampled and assigned to either treatment or control groups. Data collected at the CBOs will be aggregated by the CBO managers, and those in the treatment group will receive feedback on their performance on a monthly basis. Those in the treatment group will additionally receive a management training to guide their management practices. Researchers hypothesize that there will be improvements in management indicators and therefore decreases in costs at CBOs in the treatment group. Results will be disseminated to local, national, and international stakeholders.
- Conditions
- HIV/AIDS
- Being tested
- Management training and data feedback
- Keywords
- costing, behavioral intervention, management
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Management training and data feedbackBehavioural
The management training will consist of a variety of management topics, such as financial, workplace and staff management. The training will include a number of tools that the managers will be expected to bring back with them and use regularly at their site. There will be monthly refresher trainings for the managers via an online platform, where participants will interact about the topics covered in the training and others relevant to their work as managers. Participants will also receive monthly visualizations that compare the data that they enter via tablet monthly to both (1) their baseline data, and (2) to other sites' data. Outcomes that will be measured and reported back to sites include cost per client tested, number of condoms distributed, and number of FSW reached by educational interventions.
| Study group | Role | What they receive |
|---|---|---|
| Treatment: Management + data training | Experimental | The treatment group in the study will receive a 5-day training. The first two days of the training will consist of introducing the data collection tools and collecting baseline data. Days three through five of the training will consist of a variety of management topics.
On a monthly basis, the treatment group will receive data visualizations that will compare their site's performance that month to pervious performance and to other sites in the study. Both treatment and control groups will collect information regarding input costs and number of services provided on a monthly basis. Receives: Behavioral: Management training and data feedback |
| Control: data training only | No intervention | The control group will receive only a 2-day training which will focus on data collection alone. Both treatment and control groups will collect information regarding input costs and number of services provided on a monthly basis. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in cost per female sex worker reached by HIV education services
This measures the total cost of HIV education provision, divided by the number of female sex workers (FSWs) reached by the service.
Measured: Two years
Change in cost per female sex worker tested
This measures the total cost of HIV testing and counseling, divided by the number of FSWs tested.
Measured: Two years
Change in cost per female sex worker treated for STIs (sexually transmitted infections)
This measures the total cost of STI treatment, divided by the number of FSWs treated for any STI.
Measured: Two years
Change in cost per female sex worker tested positive
This measures the total cost of HIV testing and counseling, divided by the number of FSWs tested positive for HIV.
Measured: Two years
Secondary outcomes (4)
Productivity of HIV education
Productivity of the organizations will be measured as the number of outputs produced for the HIV education intervention-number of FSW reached by HIV education.
Measured: Two years
Productivity of HIV testing
Productivity of the organizations will be measured as the number of outputs produced for the HIV testing and counseling interventions-number of FSW tested for HIV.
Measured: Two years
Productivity of STI treatment
Productivity of the organizations will be measured as the number of outputs produced for the STI treatment intervention-number of FSW treated for STIs.
Measured: Two years
Job satisfaction
Measured through a composite score of five Likert scale questions about satisfaction, answers ranging from 1-5, 1 being "very dissatisfied" and 5 being "very satisfied".
Measured: Two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2017
- Study start12 Aug 2017
- Primary completion1 Sep 2018
- Study completion1 Dec 2019
Why it stopped: Due to defunding of USAID project that supported the majority of the sites selected in the randomization.
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
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto Nacional de Salud Publica, Mexico
- Sponsor type
- University, hospital or other
- Collaborators
- Society For Family Health (SFH), National Agency for the Control of AIDS (NACA)
- Responsible party
- Principal investigator, Sergio Bautista Arredondo, Instituto Nacional de Salud Publica, Mexico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03371914
- Sponsor's protocol ID
- INSaludPublica
- Status last verified
- Aug 2020
- First submitted
- 16 Sep 2017
- Last updated
- 5 Aug 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Bautista-Arredondo S, Nance N, Salas-Ortiz A, Akeju D, Oluwayinka AG, Ezirim I, Anenih J, Chima C, Amanze O, Omoregie G, Ogungbemi K, Aliyu SH. The role of management on costs and efficiency in HIV prevention interventions for female sex workers in Nigeria: a cluster-randomized control trial. Cost Eff Resour Alloc. 2018 Oct 23;16:37. doi: 10.1186/s12962-018-0107-x. eCollection 2018.
PubMed 30386184
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Costs, Efficiency and the Role of Management in HIV Prevention Interventions for Female Sex Workers in Nigeria
- ClinicalTrials.gov ID
- NCT03371914
- Acronym / sponsor ID
- INSaludPublica
- Conditions
- HIV/AIDS
- Keywords
- costing, behavioral intervention, management
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to defunding of USAID project that supported the majority of the sites selected in the randomization.
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Instituto Nacional de Salud Publica, MexicoUniversity, hospital or other
- Collaborators
- Society For Family Health (SFH), National Agency for the Control of AIDS (NACA)
- Study start
- 12 Aug 2017 (actual)
- Primary completion
- 1 Sep 2018 (actual)
- Study completion
- 1 Dec 2019 (actual)
- First posted
- 13 Dec 2017 (actual)
- 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.
This study seeks to measure the costs associated with HIV prevention service delivery to female sex workers (FSW) in Nigeria, as well as examine the relationship between management practices at the community-based organizations (CBOs) and costs. To complete these goals, the study will collect both retrospective and prospective data from CBOs and from centralized information from study partners (Society for Family Health, SFH). In the prospective section of the study, CBOs will be sampled and assigned to either treatment or control groups. Data collected at the CBOs will be aggregated by the CBO managers, and those in the treatment group will receive feedback on their performance on a monthly basis. Those in the treatment group will additionally receive a management training to guide their management practices. Researchers hypothesize that there will be improvements in management indicators and therefore decreases in costs at CBOs in the treatment group. Results will be disseminated to local, national, and international stakeholders.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment: Management + data training | Experimental | Behavioral: Management training and data feedbackThe treatment group in the study will receive a 5-day training. The first two days of the training will consist of introducing the data collection tools and collecting baseline data. Days three through five of the training will consist of a variety of management topics. On a monthly basis, the treatment group will receive data visualizations that will compare their site's performance that month to pervious performance and to other sites in the study. Both treatment and control groups will collect information regarding input costs and number of services provided on a monthly basis. |
| Control: data training only | No intervention | –The control group will receive only a 2-day training which will focus on data collection alone. Both treatment and control groups will collect information regarding input costs and number of services provided on a monthly basis. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Clusters: community-based organizations that serve female sex workers under Society for Family Health, through the SHIPs or Global Fund grants
- Participants: managers ("officers") that oversee the functions of the organization and supervise volunteer staff
Key exclusion criteria (2 listed)
- Clusters: excludes organizations not serving female sex workers and not working under Society for Family Health, through Global Fund or SHIPs grants
- Participants: excludes anyone not explicitly working as a manager overseeing volunteer implementation
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 |
|---|---|---|
| Management training and data feedbackThe management training will consist of a variety of management topics, such as financial, workplace and staff management. The training will include a number of tools that the managers will be expected to bring back with them and use regularly at their site. There will be monthly refresher trainings for the managers via an online platform, where participants will interact about the topics covered in the training and others relevant to their work as managers. Participants will also receive monthly visualizations that compare the data that they enter via tablet monthly to both (1) their baseline data, and (2) to other sites' data. Outcomes that will be measured and reported back to sites include cost per client tested, number of condoms distributed, and number of FSW reached by educational interventions. | Behavioural | Treatment: Management + data training |
Primary outcome
Change in cost per female sex worker reached by HIV education services
Time frame: Two years
This measures the total cost of HIV education provision, divided by the number of female sex workers (FSWs) reached by the service.
Change in cost per female sex worker tested
Time frame: Two years
This measures the total cost of HIV testing and counseling, divided by the number of FSWs tested.
Change in cost per female sex worker treated for STIs (sexually transmitted infections)
Time frame: Two years
This measures the total cost of STI treatment, divided by the number of FSWs treated for any STI.
Change in cost per female sex worker tested positive
Time frame: Two years
This measures the total cost of HIV testing and counseling, divided by the number of FSWs tested positive for HIV.
4 secondary outcomes
Productivity of HIV education
Time frame: Two years
Productivity of HIV testing
Time frame: Two years
Productivity of STI treatment
Time frame: Two years
Job satisfaction
Time frame: Two years
Results and safety
The study was stopped early (reason given: Due to defunding of USAID project that supported the majority of the sites selected in the randomization.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2020.
- Derived from this study: PubMed 30386184Bautista-Arredondo S, Nance N, Salas-Ortiz A, Akeju D, Oluwayinka AG, Ezirim I, Anenih J, Chima C, Amanze O, Omoregie G, Ogungbemi K, Aliyu SH. The role of management on costs and efficiency in HIV prevention interventions for female sex workers in Nigeria: a cluster-randomized control trial. Cost Eff Resour Alloc. 2018 Oct 23;16:37. doi: 10.1186/s12962-018-0107-x. eCollection 2018.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Management training and data feedback in people with HIV/AIDS, run by Instituto Nacional de Salud Publica, Mexico at 1 site in Nigeria.
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 2 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: stopped early, as of the sponsor's last update on 5 Aug 2020. 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 Nigeria. 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 was stopped early (reason given: Due to defunding of USAID project that supported the majority of the sites selected in the randomization.). Results are not available in the source record.
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?
Change in cost per female sex worker reached by HIV education services (time frame: Two years). The study lists 4 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 NCT03371914, 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 5 Aug 2020.