The CAPSS pilot study was successful in demonstrating that a subsidized product coupled with an intensive communication campaign leads to increased purchase and use of ACT in the private sector. There was a six-fold increase in the number of people (all age groups) and a ten-fold increase in children under five years old purchasing effective malaria treatment within 24 hours of the onset of fever. Further, over 70% of the caregivers who purchased an ACT complied with recommended treatment schedules. All the objectives set at the outset were thus achieved.
The CAPSS pilot study validates the hypothesis that affordable treatment drives availability and uptake, thereby displacing ineffective treatments, and provides evidence to support the AMFm concept. The preliminary findings from the CAPSS pilot study were shared with the AMFm task force in 2010 and provided the rationale for using the universal logo for all AMFm products
 - the CAPSS logo of “ACT with a leaf” was chosen as the AMFm product logo (“ACTm with a leaf”).
We believe the effect sizes we observed between the intervention and control areas are statistically modest compared to what could have reasonably been expected. There are two reasons for this. First, the overall ACT availability in public health facilities in the control district (Soroti) improved greatly, with three-quarters of facilities having ACT in stock in May 2010 [Uganda HMIS reports]. The contextual information suggests that there was better availability of ACT in the public sector in the control district because of improvements that had been made in the procurement and distribution system, based on a push instead of a pull system for the lower-level health units. However, this was not the case in the intervention districts. Consequently, slightly more than half of the public health facilities in Pallisa and Kaliro had no public sector ACT packs in stock at the time of the surveys; and the situation in Budaka was distressingly inadequate, with three quarters of public sector facilities having no ACT in stock. Second, the intervention made by another group (Living Goods) to improve access to ACT at community level in the control district had an impact on ACT supply there. These findings make us believe that the effect differences could have been bigger had these developments not taken place or had the public sector supply chain not failed in the intervention districts.
The private sector’s role in ensuring access to medicines is largely complementary to that of the public sector: the nature of this role is determined primarily by the level of availability in public sector outlets. When there are stock-outs in the public sector, the private sector’s role inevitably shifts from a complementary one to primary. Whether the private sector played a complementary or primary role therefore varied greatly during the different rounds of data collection. For example, in Kaliro, Pallisa and Budaka, access to ACT was largely assured through the availability of the subsidized ACT in the private sector, because stock-outs in the public sector were very frequent. However, in Kamuli, private sector availability complemented existing public sector availability. ACT access through the private sector was very low in the control district. Based on these findings, we believe that moving forward; the AMFm strategy should be tailored to the local context
. There are settings where strengthening the public sector can achieve substantial improvements in access to malaria treatment. However, in settings like Uganda, strengthening the public sector without providing complementary support from the private sector is very unlikely to achieve the WHO Global Malaria Action Plan (GMAP) case management access target that 80% of patients should receive treatment within 24 hours of symptom onset
While the CAPPS pilot study was very successful, there are several challenges that need to be addressed to ensure adequate availability in poor and remote rural areas. This requires a number of specific actions, such as incentivising suppliers to deliver medicines to such areas, or strengthening community based systems, such as that of Uganda’s village health teams. Ensuring there are sufficient licensed outlets to meet demand is also critical. In the more developed areas of Uganda, where private businesses flourish, a sufficiently large number of private outlets are able to achieve the required licensing standards. However, in other less developed areas, where there are currently few or no private licensed outlets, there is insufficient coverage. In addition, the outlets that do exist in these areas are often severely constrained, since many of the smaller outlets rely on the immediate cash flow from sales to pay for their next orders. These cash flow constraints result in the smaller outlets placing very small orders with the distributors, since they cannot afford to tie up significant amounts of money in stock. Prices in the more remote rural areas are often even higher than in urban/suburban centres, largely due to the additional costs of distribution. Enhancing access to ACTs in poorer, more remote areas requires overcoming these distribution challenges.
A second challenge is the difficulty of maintaining the maximum recommended retail price in the face of currency exchange fluctuations. The Ugandan Shilling faced ongoing devaluation during the course of this study. This resulted in the importers of “ACT with a leaf” facing higher landed costs, costs which are normally passed on to the consumers in terms of higher prices. Moreover, national drug regulatory agencies in many countries, particularly in East Africa, do not attempt to control market prices in view of price liberalization policies. Rather than imposing a maximum price, therefore, a more pragmatic approach might be to issue a “recommended retail price range” (RRPR). This would be effective in setting price expectations. The maintenance of the ACT price is also subject to the availability of the continuing subsidy; this price is consequently vulnerable to changes in the global funding landscape.
A third challenge, applying to both the public and private sectors, is the need to avoid stock-outs. Ensuring uninterrupted availability of ACT is critical to guaranteeing access to effective treatment. In this regard, the two sectors can work synergistically to improve access to treatment. A concerted effort needs to be made to ensure that more caregivers of children under five seek treatment within 24 hours of the onset of fever and have access to ACT. The introduction of rapid diagnostic tests in the public sector and subsequently in the private sector could help ensure targeting of ACT. Such an approach would ensure that patients quickly get access to the correct treatment for malaria based on parasite-based diagnosis as per current WHO recommendations
The results of the independent evaluation of the AMFm from Uganda validate the CAPSS findings of affordability driving stocking and uptake as availability of quality assured ACTs (AQ-ACT) across all outlets increased from 21% at baseline to 67% at endline
. The recommended retail price (RRP) however of USD 0.47 for an adult course of treatment was not adhered to; the median price at the endline survey was USD 1.96. The independent evaluation suggests that this may be influenced by the absence of supporting interventions before the final round of data collection due to delays in the disbursement of the Global Fund grant and the fact that only 10% of respondents knew that there was a RRP and only 5% knew the level.
Certain limitations in the design of this study need to be noted. First, the districts were purposefully selected and only one district was used as a control. This could have increased the potential for discordance between the populations included in the study. Some discordance was observed between the intervention and control districts at baseline in terms of drug consumption habits. Fortunately, the observed disparities did not include the use of ACT. Generating survey-adjusted outputs was intended to provide a more reasonable range of likely values that accounted for this prior to executing tests of significance. Second, only respondents leaving drug outlets at specific times and who consented to the interview were analysed. This could lead to both a selection and response bias. Different groups are likely to visit drug stores at different times during the day. As an example, people who are employed full-time may be more likely to visit an outlet at night. Also, we did not collect detailed information about potential respondents who refused to be interviewed. It is possible that their characteristics differed from the study sample. However, the rate of refusal was generally small (not exceeding 10%) and any effect due to refusal probably did not impact significantly on the outcome measures. Further, the wide range of times at which interviews were conducted, in combination with survey-adjustment, minimized the influence of these possible biases. Finally, a possible observer bias could arise from the fact that the interviewers were not blinded to the intervention status of the respondents. To mitigate this risk, a week long training session was administered prior to each round of data collection to instil strict processes for conducting interviews and to prevent - to the extent possible - deviation from the script. It is unlikely that this lack of blinding could influence the primary outcome in this study, as it was obligatory for the interviewer to observe and record the details of the actual medicine purchased.