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Costs, Efficiency and the Role of Management in HIV Prevention Interventions for Female Sex Workers in Nigeria

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03371914
Recruitment Status : Terminated (Due to defunding of USAID project that supported the majority of the sites selected in the randomization.)
First Posted : December 13, 2017
Last Update Posted : August 5, 2020
Sponsor:
Collaborators:
Society For Family Health (SFH)
National Agency for the Control of AIDS (NACA)
Information provided by (Responsible Party):
Sergio Bautista Arredondo, Instituto Nacional de Salud Publica, Mexico

Brief 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. 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.

Condition or disease Intervention/treatment Phase
HIV/AIDS Behavioral: Management training and data feedback Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Costs, Efficiency and the Role of Management in HIV Prevention Interventions for Female Sex Workers in Nigeria
Actual Study Start Date : August 12, 2017
Actual Primary Completion Date : September 1, 2018
Actual Study Completion Date : December 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Experimental: Treatment: Management + data training

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.

Behavioral: Management training and data feedback
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.

No Intervention: Control: data training only
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.



Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.


Secondary Outcome Measures :
  1. Productivity of HIV education [ Time Frame: Two years ]
    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.

  2. Productivity of HIV testing [ Time Frame: Two years ]
    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.

  3. Productivity of STI treatment [ Time Frame: Two years ]
    Productivity of the organizations will be measured as the number of outputs produced for the STI treatment intervention-number of FSW treated for STIs.

  4. Job satisfaction [ Time Frame: Two years ]
    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".



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03371914


Locations
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Nigeria
Society for Family Health, Headquarters
Abuja, Nigeria
Sponsors and Collaborators
Instituto Nacional de Salud Publica, Mexico
Society For Family Health (SFH)
National Agency for the Control of AIDS (NACA)
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Sergio Bautista Arredondo, Director of Health Economics, Instituto Nacional de Salud Publica, Mexico
ClinicalTrials.gov Identifier: NCT03371914    
Other Study ID Numbers: INSaludPublica
First Posted: December 13, 2017    Key Record Dates
Last Update Posted: August 5, 2020
Last Verified: August 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sergio Bautista Arredondo, Instituto Nacional de Salud Publica, Mexico:
costing
behavioral intervention
management
Additional relevant MeSH terms:
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Acquired Immunodeficiency Syndrome
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
Immunologic Deficiency Syndromes
Immune System Diseases