The World Health Organisation reported from 2008 informations that of the over 2 million kids populating with HIV/AIDS, the bulk live in sub-Saharan Africa and acquired the infection from their HIV-positive female parents during gestation, birth or suckling [ 1 ] . Babies born with HIV have a black mentality for endurance ; it is estimated that tierce of them would hold died by the age of one twelvemonth and that by the age of two old ages, half of them would hold died [ 2 ] . The UNAIDS 2008 study on the planetary AIDS epidemic recommends the planetary execution of PMTCT intercessions as a consequence of grounds that they are effectual in forestalling neonatal HIV infection [ 3 ] . This PMTCT programme in a sub-Saharan African developing state hence targets its HIV/AIDS intercessions at HIV-positive pregnant adult females. Its execution is guided by the National HIV/AIDS policy which has identified and adopted the bar of mother-to-child transmittal of HIV as one of its cardinal schemes “ to better upon the state ‘s response [ to HIV/AIDS ] by adequately turn toing the unmarked constituents… to guarantee that the HIV/AIDS epidemic is brought under control… ” [ 4 ] . PMTCT intercessions vary and in assorted scenes have undergone rating utilizing methods such as randomised double-blind placebo-controlled tests [ 5 ] , experimental cohort surveies [ 6 ] , and retrospective surveies [ 7 ] .
To cut down the incidence of HIV in the general population by conveying about a decrease in the figure of babes born with HIV.
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To do the PMTCT service available to all pregnant adult females in an just mode
To increase the figure of pregnant adult females who have entree to HIV showing and PMTCT intervention
To increase the figure of pregnant adult females who accept to hold HIV testing done
To offer HIV positive pregnant adult females an effectual, safe and acceptable intervention to forestall HIV transmittal to their babies
To increase the figure of HIV positive pregnant adult females who consent to have PMTCT intervention
To supply mechanisms to better drug attachment in order to enable patients finish their intervention regimen as prescribed
To maximize the programme coverage
To successfully forestall HIV infection in newborn babes
To diminish the incidence of HIV-associated infant morbidity and mortality
To increase the HIV-free endurance of HIV-exposed babies
To cut down the incidence of HIV in the general population
The range of the PMTCT programme includes:
HIV guidance and testing to all pregnant adult females go toing the prenatal clinic
Reding given before and after the HIV trial to each patient
Provision of free standardised PMTCT intervention to those who test positive to HIV and consent to be treated which entails:
Oral antiretroviral HIV medicine to be taken 12-hourly as from 28 hebdomads of gestation with or without repasts until the oncoming of labor
A separate individual tablet to be swallowed every bit shortly as labor Begins
A class of 12-hourly medicines to be taken after bringing with or without repasts up till one hebdomad after bringing
HIV medicine administered to the neonates from birth until six ( 6 ) hebdomads of life
HIV testing for babes at birth and six ( 6 ) hebdomads
Attachment reding given before beginning and throughout the continuance of intervention government
Regular clinic assignments to confer with with the physicians, undergo research lab monitoring trials, pick up medicines and receive reding on drug attachment and infant eating options
Provision of diagnostic trials and free intervention for other infections such as TB
Provision of drugs for neonates after birth
HIV showing trials for babes after birth to find HIV position
Provision of pediatric HIV intervention for HIV positive babes
Community outreach programmes to increase public consciousness of the service
Regular preparation of staff presenting guidance, showing, other trials and intervention
Hosting of monthly support group meetings
The programme employs physicians, nurses, counselors, druggists, administrative staff, records officers, cleaners, security guards, and laboratory scientists.
The premises used for the bringing of the service are provided at no cost to the programme.
The fiscal budget varies from twelvemonth to twelvemonth and that for the current fiscal twelvemonth is ?X. The budgets is used to cover recurrent costs such as public-service corporation measures, staff wage, care of equipment, proviso of consumables, staff preparation, procurance of drugs, and the running of consciousness runs.
The standards for measuring the accomplishment of the programme aims will necessitate to be decided in concurrence with the rating users and the representatives of other stakeholders such as the province and federal ministries of wellness, patients and their households and other service suppliers nevertheless the following have been put frontward and are unfastened to treatment:
Extensive programme coverage
Decrease in the incidence of HIV in the population over clip
Decrease in infant mortality rates over clip
Decrease in under-5 mortality rates over clip
Decrease in the incidence of babes born with HIV over clip
An addition in the figure of HIV infections prevented
Increased consumption of HIV testing among pregnant adult females go toing the prenatal clinic
Increased proportion of adult females who screen positive to HIV traveling on to hold PMTCT intervention
Good representation of all social groups in adult females who attend the clinic
Widespread public consciousness and credence of the programme
Further inside informations of the service
The stakeholders include the programme funders, the direction and staff of the PMTCT programme, the direction and staff of the infirmary supplying the prenatal attention services, representatives of province and federal ministries of wellness, all HIV positive pregnant adult females, their spouses/partners, parents, kids, siblings, other household and friends.
The service commenced in 2003 and was to the full operational by the terminal of 2005. While a service alteration is being contemplated, this would depend on the rating findings and there are no deadlines to be met at the present clip.
The PMTCT programme is run from a hospital-based PMTCT clinic which is a sub-unit of a larger HIV/AIDS intervention service. The mark population of the clinic is all pregnant adult females go toing the prenatal clinic on the infirmary premises.
There are steps steadfastly in topographic point which have ensured elaborate and extended informations aggregation on all the activities of the programme. This information is stored both electronically and in paper registries.
There have non been any major alterations in the programme bringing since its execution.
Audited account and experimental-economic rating
Policy shapers, directors and wellness practicians
This rating has three purposes:
To measure the overall quality of the service
To measure the effectivity of the service
To transport out an economic rating to supply an grounds base for determinations sing a proposed alteration of the intervention presently offered
The rating inquiries are as follows:
Effectiveness and Quality of the service
Is there an equal staff figure to present the service?
Is the appropriate proficient equipment available for usage?
What is the rate of complications/adverse events from intervention?
How accessible is the service to patients and their households in footings of cognition of its being, distance, terrain and cost of travel?
Are the societal, cultural and spiritual values of the patients and their households taken into history and respected by the programme?
What is the programme coverage?
What is the bar rate of the programme?
Is it relevant with regard to the demands of the clients and the larger communities?
Are the patients satisfied with the services they receive?
Is the service being delivered in an just mode?
What is mean waiting clip to acquire attended to in the clinic?
What are the ways in which this service may be improved?
There is a direction committedness to implement the utile findings from the rating in a systematic, practical and sustainable manner bearing in head the restrictions of the sanctioned fiscal budgets and steering authorities policies. In peculiar, the rating is expected to assist the policy shapers, directors and practicians with a determination sing a alteration of the PMTCT intervention protocol presently in usage.
The rating was commissioned by the direction squad of the programme with the blessing of the support spouses.
A maneuvering group shall be formed and will represent of the judges and representatives from each of the undermentioned groups: the national and province policy shapers, the support spouses, the direction squad, the practicians, the patients and their households and the infirmary supplying prenatal attention services. This group will keep regular meetings to supervise the rating.
The stakeholders stand foring the pregnant adult females would besides be an priceless resource with assisting to plan a questionnaire to measure facets of service quality such as relevancy, acceptableness and ways in which the service may be improved. We would wish to ask for the physicians and nurses to discourse the rating design with us, supply penetration based on their personal experience of presenting the service and aid with informations aggregation.
We would wish to province here and repeat at the stakeholder meetings that the intent of the rating is non to knock the programme or its staff but instead to acknowledge what is already being done good and clarify and understand the barriers to execution in identified countries of sub-optimal service bringing.
Timing and resources
The continuance of the rating would depend on the degree of aid made available for informations aggregation. No deadlines have been given for the entry of the rating study but excluding any unanticipated fortunes it is estimated that the findings should be ready for presentation in 11 ( 11 ) months.
The support for the rating is to cover the costs of staff wage, transit, telephone measures and stationary. Office infinite within the programme premises from which to organize the activities would be required and the services of a statistician would necessitate to be engaged for some facets of the survey design such as the appraisal of sample size and power.
Design of the Evaluation
Problem to be analyzed
The PMTCT intervention protocol presently in usage recommends that the intervention be commenced at 28 hebdomads of gestation
Importance of job
There have been observations that important Numberss of adult females who get recruited into the programme at early phases of gestation terminal up non having the PMTCT intercession
This has been attributed to the patients ‘ perceptual experience after several clinic visits without having intervention that the programme is a waste of their clip
Further account of job
The direction, in concurrence with the practicians, is hence sing the earlier establishment of drug therapy at 20 hebdomads of gestation in an attempt to forestall patients from defaulting
Questions to be answered
What is the cost of implementing PMTCT intervention at 20 hebdomads of gestation?
Will this new protocol efficaciously prevent the transmittal of the HIV infection from the female parents to their neonates?
Funders, who would wish to cognize the cost deductions of a intervention alteration every bit good as the possible benefits such as better wellness results and increased use of services
Practitioners, who are interested in bettering the service coverage and effectivity
The position of the service suppliers will be taken as it is non anticipated that the patient will incur any extra costs
Six months for the intervention of both the female parents and the babies
Eleven months as the concluding result step which will be assessed is the infant HIV position at 6 months
Type of rating
Quasi-experimental design ; Non-randomized controlled test
Target of intercession
HIV positive pregnant adult females
Womans recruited freshly into the programme will be allocated into two intervention groups based on their gestational age
One group will be made up of adult females who are less than or equal to twenty hebdomads pregnant while the other group will be made up of adult females who are more than 20 hebdomads and up to 28 hebdomads pregnant
The services received by both groups will be indistinguishable in all respects except for the clip of beginning of the drug intervention
Group 1 ( new intervention ) will get down taking drugs at 20 hebdomads of gestation and group 2 ( old intervention ) will get down at 28 hebdomads of gestation
Treatment group 1
Allocation HIV position of babe
Treatment group 2
Costss included in the cost effectivity analysis
Costss of drugs administered
Forces clip such as attachment counselors, druggists, laboratory staff
Supplies like prescription sheets
Outcome step under probe
HIV position of babies at 6 months after bringing
Cost per HIV infection prevented for each of the two intervention groups will be calculated
A top-down attack will be used since there is a individual diagnosing and a uniformity of intervention within each group.
Incremental cost-effectiveness ratio=Cost of intervention 1 ( C1 ) – Cost of intervention 2 ( C2 )
Result of intervention 1 ( Q1 ) – Result of intervention 2 ( Q2 )
There are 4 possible results of the above equation:
Treatment 1 may be more expensive than intervention 2 but present a better result.
Treatment 1 may be less expensive than intervention 2 and present a lower result.
Treatment 1 may be more expensive than intervention 2 yet deliver poorer results.
Treatment 1 may be less expensive than intervention 2 yet present a better result.
Result 4 would favor a alteration in intervention protocols while outcome 3 regulations it out.
Outcomes 1 and 2 would necessitate to be decided in relation to how much more or less effectual the intervention is in relation to the difference in cost.
Other quantitative steps
The proportion of HIV exposed babies whose female parents received PMTCT
HIV incidence in the general population
Baby and under-5 mortality rates
Features of the patient population
These will be targeted at patients, suppliers and the wider community and shall take the signifier of:
Focus group treatments
This has been classified harmonizing to the point of information, the beginning of information and the method by which this information will be collected and is presented in the tabular array below.
Item of information
Method of aggregation
Number of programme staff by class
Programme equipment types and figure
Overall cost of presenting the service
Detailed dislocation of costs of staff wage, drugs, public-service corporations, care, staff preparation and consumables
Incidence of HIV in the general population
Prevalence of HIV in pregnant adult females
Documents and records
Patient Numberss and socio-demographic features of patients
Number of happenings of drug inauspicious effects and inside informations
Incidence of patient defaulting and inside informations
Attendance Numberss at the prenatal clinic
Number of adult females go toing the prenatal clinic who receive reding for HIV testing
Number of adult females go toing the prenatal clinic who consent to be screened
Number of adult females go toing the prenatal clinic who test positive to HIV
Number of adult females who receive a complete class of PMTCT intervention
Number of adult females go toing the prenatal clinic and tested positive to HIV accepting to have PMTCT intervention
Number of babies found to be HIV positive after their female parents received PMTCT intervention
Number of babies found to be HIV negative after their female parents received PMTCT intervention
Routinely collected information
Routinely collected information
Accessibility, acceptableness, and relevancy of programme to patient demands
Patient satisfaction with and consciousness of the programme
Barriers to the consumption of HIV showing, PMTCT intervention and drug conformity
Practitioners ‘ position sing barriers to patient consumption of showing, PMTCT intervention and drug conformity.
Individual stakeholders and groups of stakeholder
Monitoring of activities
Focus group treatments
The information to be used, beginnings and the methods of aggregation will be reviewed with the maneuvering group to measure rightness and do accommodations as necessary. Questionnaires will later be designed, piloted and modified consequently if need be. Actual aggregation of informations will be carried out by the judges in concurrence with members of the programme staff on a voluntary footing or as allocated by the programme direction. Members of the patient support group will besides be invited to take part in facets such as the disposal of questionnaires and interested parties shall have the appropriate interviewer preparation to enable them transport out the undertaking.
We propose to get down the aggregation of informations every bit shortly as a consensus has been reached on all antecedently mentioned countries. Confidentiality of relevant informations shall be maintained at all times. We aim to maximize engagement of patients in the studies and the RCT by foregrounding to them the fact that it would be an chance for them to hold a say in how the service they use gets delivered and assist to better quality. The fact that a big sum of the informations to be used for the rating comes from informations which has already been collected we do non imagine any break of the daily running of the programme. There would nevertheless be a little addition in the work loads of the practicians as we work together on the economic rating but all attempts shall be made in concurrence with them to maintain this within sensible bounds.
The socio-demographic features of the patient population will be summarised in saloon and/or pie charts.
The results of the economic rating shall be compared utilizing their incremental cost-effectiveness ratios.
Projected Time frame for Evaluation
Draft content of questionnaire and interviews
Pilot questionnaire and interview agendas
Collate and analyze routinely collected information
Finalise questionnaire and interview agendas
Conduct questionnaire study
Recruit patients into survey
Commence intervention of female parents in survey
Treatment of babies in survey
HIV testing of babies
Analyse questionnaire, interview and survey informations
Gantt chart ( modified from NHS Nottinghamshire county Research and Evaluation Team with thanks )
Management and administration
Ethical issues taken into history in the design of this rating are confidentiality of information, namelessness of topics, the proviso of good intervention, and written informed consent, all of which shall be purely observed. Ethical blessing has been obtained for the behavior of this rating.
Monthly meetings are traveling to be scheduled between the judges and the maneuvering group to step and record advancement against the antecedently outlined agenda, discuss challenges, proffer solutions and modify scheme.
The timescale for bring forthing the concluding study has been tentatively set at 11 months from the beginning of the rating and this is chiefly with regard to the findings of the economic rating. Preliminary studies on service quality and effectivity should be ready within six months.
The bill of exchange study will be fed back to the maneuvering group for their reappraisal and positions and all feedback will be carefully considered. The concluding study will be made available to all stakeholder groups, any wider airing will be left to the discretion of the commissioners of the rating nevertheless the judges would wish to print their findings and shall keep the namelessness of the service in such literature.
1. WHO. Ten Facts on HIV/AIDS. Accessed on 30th January, 2010 ; Available from: & lt ; hypertext transfer protocol: //www.who.int/features/factfiles/hiv/facts/en/index6.html & gt ; .
2. WHO. Antiretroviral therapy of HIV infection in babies and kids. Accessed on 30th January, 2010 ; Available from: & lt ; hypertext transfer protocol: //www.who.int/hiv/pub/paediatric/infants/en/ & gt ; .
3. UNAIDS. 2008 Report on the planetary AIDS epidemic. Accessed on 30th January, 2010 ; Available from: & lt ; hypertext transfer protocol: //data.unaids.org/pub/GlobalReport/2008/jc1510_2008_global_report_pp95_128_en.pdf & gt ; .
4. NACA. National HIV/AIDS policy. Accessed on 30th January, 2010 ; Available from: & lt ; hypertext transfer protocol: //www.naca.gov.ng/index.php? option=com_content & A ; task=view & A ; id=75 & A ; Itemid=113 & gt ; .
5. Connor, E.M. , et al. , Reduction of maternal-infant transmittal of human immunodeficiency virus type 1 with Retrovir intervention. Pediatric AIDS Clinical Trials Group Protocol 076 Study Group. New England Journal of Medicine, 1994. 331 ( 18 ) : p. 1173-80.
6. Geddes, R. , et al. , Prevention of mother-to-child transmittal of HIV programme: low perpendicular transmittal in KwaZulu-Natal, South Africa. South African Medical Journal Suid-Afrikaanse Tydskrif Vir Geneeskunde, 2008. 98 ( 6 ) : p. 458-62.
7. Magoni, M.M. , et al. , Implementation of a programme for the bar of mother-to-child transmittal of HIV in a Ugandan infirmary over five old ages: challenges, betterments and lessons learned. International Journal of STD & A ; AIDS, 2007. 18 ( 2 ) : p. 109-113.