Plain English Summary
Background and study aims
HIV/AIDS has rolled back decades of socio-economic development in Sub Saharan Africa. While there are indications of declining HIV infection rates in the general population, men who have sex with men (MSM), female sex workers (FSW) and people who inject drugs (PWIDS), now called Key Populations (KP) for HIV epidemic have 2-20 times higher infections rates and contributes up to 30% of new HIV infection. Despite such high infection rates, only a third has access to health services due to stigma and discriminations. The overall objective of this study is to increase access to health services among key populations through studying factors which influence the use of health services among them and test the effectiveness of healthcare worker and peer to peer engagement in improving access to comprehensive HIV intervention package among HIV at-risk population in Tanzania.
Who can participate?
Adults who inject drugs, men who regularly or occasionally engage in sexual relationships with other men, women who exchange sex for goods or money and healthcare workers.
What does the study involve?
The study involves the promotion of key population friendly facilities through training of healthcare workers on the comprehensive HIV intervention package and developing a cadre of peers to support health access. This will be done in Dar es salaam as an intervention region and Tanga region will be used as a control region.
What are the possible benefits and risks of participating?
Enrolling in the study will improve access to health services among study participants hence better health.
Where is the study run from?
The study will take place at the Muhimbili University of health and Allied Sciences Dar es salaam, Tanzania.
When is the study starting and how long is it expected to run for?
The study is planned to take place from May, 2017 to April, 2021.
Who is funding the study?
The Danida Fellowship Centre (DFC) through grant No 16-P03-TAN.
Who is the main contact?
Prof. Elia John Mmbaga (eliajelia@yahoo.co.uk).
Study website
Contact information
Type
Scientific
Contact name
Prof Elia John Mmbaga
ORCID ID
http://orcid.org/0000-0003-3768-0225
Contact details
Muhimbili University of Health and Allied Sciences
9 United nations Road
P.O.Box 65015
Dar es Salaam
-
Tanzania
+255 22 250302
ejohn@muhas.ac.tz
Additional identifiers
EudraCT/CTIS number
Nil known
IRAS number
ClinicalTrials.gov number
Nil known
Protocol/serial number
16-P03-TAN
Study information
Scientific title
Access to health services for key populations in Tanzania: a quasi-experimental design
Acronym
DANIDA KP
Study hypothesis
1. An interplay between individual, interpersonal, contextual, structural, and sociocultural and health system factors influence health service access among KP.
2. Integration of CHPs in the existing health system is feasible, sustainable and cost-effective.
3. Intervention delivery modalities developed by and for KP sustainably improve access to CHIPs for KP.
4. Building KP research capacity through masters and PhD training will increase the generation of new evidence and intervention evaluation.
Ethics approval(s)
Approved 15/03/2016, Muhimbili University of Health and Allied Sciences Ethics Committee (P.O.Box 65001; 022 2152489; drp@muhas.ac.tz), ref: 2016-03/AEC/Vol. IX/197.
Study design
Quasi Experimental Design
Primary study design
Interventional
Secondary study design
Non randomised study
Study setting(s)
Community
Study type
Prevention
Patient information sheet
Not available in web format, please use contact details to request a participant information sheet
Condition
HIV infection
Intervention
Healthcare workers Training
Selected health care workers will be trained on the delivery of the comprehensive Intervention package for HIV which will include modules on prevention, HIV and STI testing, HIV treatment with ART, psychosocial counselling and violence mitigation.
Peer-to peer mentoring
Selected members of the key population will be trained and peer mentors on how to navigate their fellows to health facilities, linkage to KP friendly facilities and violence prevention.
Training timing
Training will be done during the second year and booster training is done after 12 months of follow up.
Participants follow up
Participants will be followed up after 12 months and 24 months following the intervention.
Intervention type
Behavioural
Primary outcome measure
The proportion of the population at risk accessing HIV services is determined using questionnaire (if one has ever gone to a health facility during the past 12 months when one had STI or general conditions) at baseline, month 12 and 24 following the intervention.
Secondary outcome measures
1. Safer sexual behaviors are measured using Questionnaire (condom use at last sexual act, number of sexual partners past 12 months at baseline, months 12 and 24 following the intervention.
2. Number of PhD trained is measured using project records on the number of project affiliated PhD graduates at the end of the project (months 60).
3. Integration of high-risk group services into the existing health system is measured using health facility records of the number of health care workers and the number of the key population seeking services in the 4 selected health facilities involved in the project at baseline, month 12 and month 24.
Overall study start date
01/05/2017
Overall study end date
30/04/2021
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Aged 18 or above and injects drugs.
2. Men who regularly or occasionally engage in sexual relationships with other men aged 18 and above.
3. Women who exchange sex for goods or money.
4. Health care workers aged 18 or above.
Participant type(s)
Other
Age group
Adult
Lower age limit
18 Years
Sex
Both
Target number of participants
900 in intervention region and 900 from the control region (Total 1800)
Participant exclusion criteria
1. Refuse to provide informed consent.
2. Not a resident of a participting region.
2.1. Do not have and address and have not lived there for the past six months.
3. Have mental illness or are too sick to participate.
Recruitment start date
01/11/2017
Recruitment end date
31/03/2021
Locations
Countries of recruitment
Tanzania
Study participating centre
Muhimbili University of Health and Allied Sciences
P.o.Box 65016
9 United Nation Road
Dar es Salaam
+255
Tanzania
Sponsor information
Organisation
Danida Fellowship Centre DFC
Sponsor details
Hostrupsvej 22
Frederiksberg
1950
Denmark
+45 3536 1322
research@dfcentre.dk
Sponsor type
Research council
Website
https://dfcentre.com/about-us/contact/
ROR
Funders
Funder type
Research council
Funder name
Danida Fellowship Centre
Alternative name(s)
DFC
Funding Body Type
private sector organisation
Funding Body Subtype
Other non-profit organizations
Location
Denmark
Results and Publications
Publication and dissemination plan
1. Key population Community Advisory Board
2. Local and International Conferences
3. Local Internation seminars and symposium
4. Peer reviewied Journal Publication
Intention to publish date
01/04/2019
Individual participant data (IPD) sharing plan
The datasets generated during and/or analysed during the current study are/will be available upon request from Prof. Elia John Mmbaga (eliajelia@yahoo.co.uk). Quantitative and qualitative data anonymized and will be available after publications or end of project on reasonable request.
IPD sharing plan summary
Available on request
Study outputs
Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
---|---|---|---|---|---|
Protocol article | protocol | 06/11/2019 | 08/11/2019 | Yes | No |